Search by Drug Name or NDC

NDC 82123-0001-81 Sunscreen SPF30 12 mg/80mL Details

Sunscreen SPF30 12 mg/80mL

Sunscreen SPF30 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI. The primary component is ZINC OXIDE.

Product Information

NDC	82123-0001
Product ID	82123-001_ed6d4540-2c1d-734d-e053-2995a90a0d84
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Sunscreen SPF30
Proprietary Name Suffix	n/a
Non-Proprietary Name	Non Nano Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	12
Active Ingredient Units	mg/80mL
Substance Name	ZINC OXIDE
Labeler Name	SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2023-12-31

Package

Package Images

NDC 82123-0001-81 (82123000181)

Pricing Information	N/A
NDC Package Code	82123-001-81
Billing NDC	82123000181
Package	1 TUBE in 1 TUBE (82123-001-81) / 80 mL in 1 TUBE (82123-001-80)
Marketing Start Date	2021-06-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c5d52f13-a649-9579-e053-2a95a90a062c Details

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

in children less than 2 months of age
on open skin wounds

SPL UNCLASSIFIED SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Package Label - Principal Display Panel

Sunscreen SPF3080 mL NDC: 82123-001

PRINCIPAL DISPLAY PANEL

Sunscreen for kids SPF5080 mL NDC: 82123-002

PRINCIPAL DISPLAY PANEL

Sunscreen for face SPF3040 mL NDC: 82123-003

PRINCIPAL DISPLAY PANEL

AfterSun80 mL NDC: 82123-004

PRINCIPAL DISPLAY PANEL

Diaper Rash Cream50 mL NDC: 82123-005

PRINCIPAL DISPLAY PANEL

SOS Cream

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF30

non nano zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82123-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 mg in 80 mL

Ingredient Name	Strength
Inactive Ingredients
XYLITYL SESQUICAPRYLATE (UNII: YQ8NMJ5QFY)
WATER (UNII: 059QF0KO0R)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
JOJOBA OIL (UNII: 724GKU717M)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
WHITE WAX (UNII: 7G1J5DA97F)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
PANTHENOL (UNII: WV9CM0O67Z)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARGAN OIL (UNII: 4V59G5UW9X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82123-001-81	1 in 1 TUBE	06/28/2021
1	NDC:82123-001-80	80 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	06/28/2021

SUNSCREEN FOR FACE SPF30

non nano zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82123-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 mg in 40 mL

Ingredient Name	Strength
Inactive Ingredients
XYLITYL SESQUICAPRYLATE (UNII: YQ8NMJ5QFY)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PANTHENOL (UNII: WV9CM0O67Z)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
GLYCERYL CITRATE (UNII: 4987GT719I)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
WHITE WAX (UNII: 7G1J5DA97F)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
ARGAN OIL (UNII: 4V59G5UW9X)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82123-003-41	1 in 1 TUBE	06/28/2021
1	NDC:82123-003-40	40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	06/28/2021

AFTERSUN

non nano zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82123-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.6 mg in 80 mL

Ingredient Name	Strength
Inactive Ingredients
XYLITYL SESQUICAPRYLATE (UNII: YQ8NMJ5QFY)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL CITRATE (UNII: 4987GT719I)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
WHITE WAX (UNII: 7G1J5DA97F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
SESAME OIL (UNII: QX10HYY4QV)
XANTHAN GUM (UNII: TTV12P4NEE)
ARGAN OIL (UNII: 4V59G5UW9X)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82123-004-81	1 in 1 TUBE	06/28/2021
1	NDC:82123-004-80	80 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	06/28/2021

DIAPER RASH CREAM

non nano zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82123-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11 mg in 50 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
WHITE WAX (UNII: 7G1J5DA97F)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
PANTHENOL (UNII: WV9CM0O67Z)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
JOJOBA OIL (UNII: 724GKU717M)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
PALM OIL (UNII: 5QUO05548Z)
PALM KERNEL OIL (UNII: B0S90M0233)
COCONUT OIL (UNII: Q9L0O73W7L)
CANOLA OIL (UNII: 331KBJ17RK)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82123-005-51	1 in 1 TUBE	06/28/2021
1	NDC:82123-005-50	50 mg in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	06/28/2021

SUNSCREEN FOR KIDS SPF50

non nano zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82123-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.6 mg in 80 mg

Ingredient Name	Strength
Inactive Ingredients
XYLITYL SESQUICAPRYLATE (UNII: YQ8NMJ5QFY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
PALM KERNEL OIL (UNII: B0S90M0233)
COCONUT OIL (UNII: Q9L0O73W7L)
CANOLA OIL (UNII: 331KBJ17RK)
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCERYL CITRATE (UNII: 4987GT719I)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PALM OIL (UNII: 5QUO05548Z)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82123-002-81	1 in 1 TUBE	06/28/2021
1	NDC:82123-002-80	80 mg in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	06/28/2021

S.O.S CREAM INTENSIVE MOISTURIZING SKIN PROTECTANT

non nano zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82123-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.6 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
OLEA EUROPAEA FLOWER (UNII: 498M34P1VZ)
WHITE WAX (UNII: 7G1J5DA97F)
PANTHENOL (UNII: WV9CM0O67Z)
HONEY (UNII: Y9H1V576FH)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
GLYCERIN (UNII: PDC6A3C0OX)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ROYAL JELLY (UNII: L497I37F0C)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82123-007-16	1 in 1 BOX	11/11/2021
1	NDC:82123-007-15	15 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	11/11/2021

Labeler - SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI (533166749)

Registrant - SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI (533166749)

Name	Address	ID/FEI	Business Operations
Establishment
SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI		533166749	manufacture(82123-001, 82123-002, 82123-003, 82123-004, 82123-005, 82123-007)

Revised: 11/2022

Document Id: ed6d4540-2c1d-734d-e053-2995a90a0d84

Set id: c5d52f13-a649-9579-e053-2a95a90a062c

Version: 5

Effective Time: 20221114

Search by Drug Name or NDC

NDC 82123-0001-81 Sunscreen SPF30 12 mg/80mL Details

Sunscreen SPF30 12 mg/80mL

Product Information

Package

Package Images

NDC 82123-0001-81 (82123000181)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c5d52f13-a649-9579-e053-2a95a90a062c Details

Active Ingredient(s)

Purpose

Use

Warnings

Do not use

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

Package Label - Principal Display Panel

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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