OBAGI SUN SHIELD TINT WARM SUNSCREEN BROAD SPECTRUM SPF 50- homosalate, octinoxate, titanium dioxide, zinc oxide lotion

Obagi by

Drug Labeling and Warnings

Obagi by is a Otc medication manufactured, distributed, or labeled by OMP, INC., Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Homosalate 10% Octinoxate 7.5% Titanium dioxide 3.19%	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
• ▪ children under 6 months: ask a doctor
• ▪ 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

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, glyceryl stearate, PEG-100 stearate, butylene glycol, pentylene glycol, behenyl alcohol, iron oxides, PEG-40 stearate, dimethicone, physalis angulata extract, phenoxyethanol, algae extract, glycerin, mica, sodium stearoyl lactylate, polyhydroxystearic acid, mannitol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, citric acid, squalane, alumina, stearic acid, xanthan gum, diatomaceous earth, sodium polyacrylate, disodium EDTA, ethylhexylglycerin, synthetic fluorphlogopite, polysorbate 60, zinc sulfate, chlorphenesin, tetrahexyldecyl ascorbate, tin oxide, tocopherol

Questions or comments?

1.800.636.7546

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

Principal Display Panel

OBAGI®

MEDICAL

Sun Shield

TINT

Broad

Spectrum

SPF 50

Sunscreen

Lotion

[sun icon]

WARM

Infrared

Defense

Non-comedogenic

Dermatologist tested

Net wt. 3 oz. (85 g)

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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	2.711 g  in 85 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.25 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
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 (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)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-160-10	1 in 1 CARTON	01/01/2016	12/31/2020
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 62032-160-99	25 in 1 TRAY	01/01/2016	12/31/2020
2		5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2016	12/31/2020

Labeler - OMP, INC. (790553353)