Search by Drug Name or NDC

NDC 62032-0160-10 Obagi 8.5; 6.375; 2.737; 4.25 g/85g; g/85g; g/85g; g/85g Details

Obagi 8.5; 6.375; 2.737; 4.25 g/85g; g/85g; g/85g; g/85g

Obagi is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Obagi Cosmeceuticals LLC. The primary component is HOMOSALATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	62032-0160
Product ID	62032-160_aba674be-7709-4424-a7cb-180319280978
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	Obagi
Proprietary Name Suffix	Sun Shield TINT Warm Sunscreen Broad Spectrum SPF 50
Non-Proprietary Name	Homosalate, Octinoxate, Titanium dioxide, Zinc oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	8.5; 6.375; 2.737; 4.25
Active Ingredient Units	g/85g; g/85g; g/85g; g/85g
Substance Name	HOMOSALATE; OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Obagi Cosmeceuticals LLC
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 62032-0160-10 (62032016010)

Pricing Information	N/A
NDC Package Code	62032-160-10
Billing NDC	62032016010
Package	1 TUBE in 1 CARTON (62032-160-10) / 85 g in 1 TUBE
Marketing Start Date	2019-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b1aacb4d-7ede-4aae-8d6a-afff2a057e46 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients	Purpose
Homosalate 10% Octinoxate 7.5% Titanium dioxide 3.22%	Sunscreen Sunscreen Sunscreen
Zinc oxide 5%	Sunscreen

Uses

▪: helps prevent sunburn
▪: if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

▪: For external use only
▪: Do not use on damaged 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

▪

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

▪: limit time in the sun, especially from 10 a.m.-2 p.m.
▪: wear long-sleeved shirts, pants, hats and sunglasses

▪

children under 6 months: ask a doctor

Other information

▪: store at controlled room temperature: 15°C–25°C (59°F–77°F)
▪: protect this product from excessive heat and direct sun

Inactive ingredients

Water, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Methicone, Polyglyceryl-10 Pentastearate, Butylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Pentylene Glycol, Behenyl Alcohol, Physalis Angulata Extract, Dimethicone, PEG-40 Stearate, Phenoxyethanol, Lithothamnion Calcareum Powder, Glycerin, Mica, Sodium Stearoyl Lactylate, Polyhydroxystearic Acid, Mannitol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Citric Acid, Squalane, Xanthan Gum, Alumina, Stearic Acid, Diatomaceous Earth, Sodium Polyacrylate, Disodium EDTA, Ethylhexylglycerin, Synthetic Fluorphlogopite, Polysorbate 60, Zinc Sulfate, Sorbitan Oleate, Chlorphenesin, Tetrahexyldecyl Ascorbate, Tocopherol, Tin Oxide, Iron Oxides

Questions or comments?

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC,

Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

OBAGI™

MEDICAL

Sun Shield

Broad

Spectrum

SPF 50

Sunscreen

Lotion

WARM

TINT

Infrared

Defense

Non-comedogenic

Dermatologist tested

Net wt. 3 oz. (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

INGREDIENTS AND APPEARANCE

OBAGI SUN SHIELD TINT WARM SUNSCREEN BROAD SPECTRUM SPF 50

homosalate, octinoxate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62032-160
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8.5 g in 85 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.375 g in 85 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.737 g in 85 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.25 g in 85 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
12-OXOOCTADECANOIC ACID (UNII: 31GL7GRO8F)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DOCOSANOL (UNII: 9G1OE216XY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-40 STEARATE (UNII: ECU18C66Q7)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
GLYCERIN (UNII: PDC6A3C0OX)
MICA (UNII: V8A1AW0880)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MANNITOL (UNII: 3OWL53L36A)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SQUALANE (UNII: GW89575KF9)
ALUMINUM OXIDE (UNII: LMI26O6933)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
CHLORPHENESIN (UNII: I670DAL4SZ)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
STANNIC OXIDE (UNII: KM7N50LOS6)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FERROUS OXIDE (UNII: G7036X8B5H)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
ZINC SULFATE MONOHYDRATE (UNII: PTX099XSF1)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62032-160-10	1 in 1 CARTON	12/01/2019
1		85 g 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	part352	12/01/2019

Labeler - Obagi Cosmeceuticals LLC (790553353)

Name	Address	ID/FEI	Business Operations
Establishment
Swiss-American CDMO, LLC		080170933	MANUFACTURE(62032-160)

Revised: 2/2021

Document Id: aba674be-7709-4424-a7cb-180319280978

Set id: b1aacb4d-7ede-4aae-8d6a-afff2a057e46

Version: 3

Effective Time: 20210211

Search by Drug Name or NDC

NDC 62032-0160-10 Obagi 8.5; 6.375; 2.737; 4.25 g/85g; g/85g; g/85g; g/85g Details

Obagi 8.5; 6.375; 2.737; 4.25 g/85g; g/85g; g/85g; g/85g

Product Information

Package

Package Images

NDC 62032-0160-10 (62032016010)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b1aacb4d-7ede-4aae-8d6a-afff2a057e46 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

INGREDIENTS AND APPEARANCE

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