Search by Drug Name or NDC

NDC 73563-0011-18 Sunscreen with Aloe Vera SPF 30 75; 50; 60 mg/mL; mg/mL; mg/mL Details

Sunscreen with Aloe Vera SPF 30 75; 50; 60 mg/mL; mg/mL; mg/mL

Sunscreen with Aloe Vera SPF 30 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Body One Products, Inc.. The primary component is OCTINOXATE; OCTISALATE; OXYBENZONE.

Product Information

NDC	73563-0011
Product ID	73563-011_d1ff5e22-6219-404c-9a2f-b9862dba0c36
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 with Aloe Vera SPF 30
Proprietary Name Suffix	n/a
Non-Proprietary Name	Octinoxate, Octisalate, and Oxybenzone
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	75; 50; 60
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	OCTINOXATE; OCTISALATE; OXYBENZONE
Labeler Name	Body One Products, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 73563-0011-18 (73563001118)

Pricing Information	N/A
NDC Package Code	73563-011-18
Billing NDC	73563001118
Package	532 mL in 1 BOTTLE, PLASTIC (73563-011-18)
Marketing Start Date	2020-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9ab0b2d5-2c1c-4e6f-9ed7-10d3f1009e63 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredients	Purpose
Octinoxate 7.5%	Sunscreen
Octisalate 5.0%	Sunscreen
Oxybenzone 6.0%	Sunscreen

Uses

*: Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do Not Use on damaged skin or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If swallowed , get medical help or contact a Poison Control Center right away.

Directions

*: Apply liberally 15 minutes before sun exposure.
*: Use a water resistant sunscreen if swimming or sweating.
*: Reapply at least every 2 hours.
*: Children under 6 months: ask a Doctor.

Other Information

Protect this product container from excessive heat and direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Brassica Campestris/Aleurites Fordi Oil Copolymer, Butyl Paraben, Carbomer, Dimethicone, Ethylparaben, Fragrance,Glyceryl Stearate SE, Isobutylparaben, Lanolin Alcohol, Methylparaben,Mineral Oil, Phenoxyethanol, Propylparaben, Stearic Acid , Water.

Questions or Comments?

Call 1-800-544-8800

PRINCIPAL DISPLAY PANEL - 532 ML Bottle Label

BodyOne

Products

SUN SCREEN

SPF 30 LOTION

(18 FL.OZ. 532ML)

Principal Display Panel - 532 ML Bottle Label

INGREDIENTS AND APPEARANCE

SUNSCREEN WITH ALOE VERA SPF 30

octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73563-011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Allantoin (UNII: 344S277G0Z)
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) (UNII: Z135WT9208)
GULOSE, L- (UNII: J96E9Q45N7)
Mineral Oil (UNII: T5L8T28FGP)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
Stearic Acid (UNII: 4ELV7Z65AP)
Aloe vera leaf (UNII: ZY81Z83H0X)
Phenoxyethanol (UNII: HIE492ZZ3T)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Cetostearyl alcohol (UNII: 2DMT128M1S)
Polysorbate 60 (UNII: CAL22UVI4M)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73563-011-01	3785 mL in 1 JUG; Type 0: Not a Combination Product	02/01/2020
2	NDC:73563-011-18	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	02/01/2020

Labeler - Body One Products, Inc. (117376115)

Registrant - BMC 1092,Inc dba Solo Laboratories Inc. (078831987)

Name	Address	ID/FEI	Business Operations
Establishment
BMC 1092,Inc dba Solo Laboratories Inc.		078831987	MANUFACTURE(73563-011)

Revised: 1/2020

Document Id: d1ff5e22-6219-404c-9a2f-b9862dba0c36

Set id: 9ab0b2d5-2c1c-4e6f-9ed7-10d3f1009e63

Version: 1

Effective Time: 20200131

Search by Drug Name or NDC

NDC 73563-0011-18 Sunscreen with Aloe Vera SPF 30 75; 50; 60 mg/mL; mg/mL; mg/mL Details

Sunscreen with Aloe Vera SPF 30 75; 50; 60 mg/mL; mg/mL; mg/mL

Product Information

Package

Package Images

NDC 73563-0011-18 (73563001118)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 9ab0b2d5-2c1c-4e6f-9ed7-10d3f1009e63 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Directions

Other Information

Inactive Ingredients

Questions or Comments?

PRINCIPAL DISPLAY PANEL - 532 ML Bottle Label

INGREDIENTS AND APPEARANCE

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