Label: OBAGI SUN SHIELD TINT COOL SUNSCREEN BROAD SPECTRUM SPF 50- homosalate, octinoxate, titanium dioxide, zinc oxide lotion
- NDC Code(s): 62032-150-10
- Packager: Obagi Cosmeceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 11, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
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- helps prevent sunburn
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- 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
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Directions
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- apply liberally 15 minutes before sun exposure
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- use a water resistant sunscreen if swimming or sweating
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- reapply at least every 2 hours
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- children under 6 months: Ask a doctor
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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:
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- limit time in the sun, especially from 10 a.m.-2 p.m.
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- wear long-sleeved shirts, pants, hats and sunglasses
- Other information
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Inactive ingredients
water, butyloctyl salicylate, caprylic/capric triglyceride, caprylyl methicone, polyglyceryl-10 pentastearate, glyceryl stearate, PEG-100 stearate, butylene glycol, pentylene glycol, behenyl alcohol, PEG-40 stearate, dimethicone, physalis angulata extract, algae extract, glycerin, iron oxides, phenoxyethanol, sodium stearoyl lactylate, polyhydroxystearic acid, mannitol, mica, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, citric acid, squalane, alumina, stearic acid, xanthan gum, calcium aluminium borosilicate, diatomaceous earth, Sodium Polyacrylate, disodium EDTA, synthetic fluorphlogopite, polysorbate 60, ethylhexylglycerin, zinc sulfate, Sorbitan Oleate, silica, chlorphenesin, tetrahexyldecyl ascorbate, tin oxide, tocopherol
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
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INGREDIENTS AND APPEARANCE
OBAGI SUN SHIELD TINT COOL SUNSCREEN BROAD SPECTRUM SPF 50
homosalate, octinoxate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-150 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 2.703 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) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) PEG-40 STEARATE (UNII: ECU18C66Q7) DIMETHICONE (UNII: 92RU3N3Y1O) PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG) POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701) FUCUS VESICULOSUS (UNII: 535G2ABX9M) GLYCERIN (UNII: PDC6A3C0OX) FERRIC OXIDE RED (UNII: 1K09F3G675) PHENOXYETHANOL (UNII: HIE492ZZ3T) PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MANNITOL (UNII: 3OWL53L36A) MICA (UNII: V8A1AW0880) 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) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) XANTHAN GUM (UNII: TTV12P4NEE) ZINC SULFATE MONOHYDRATE (UNII: PTX099XSF1) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYSORBATE 60 (UNII: CAL22UVI4M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FERROUS OXIDE (UNII: G7036X8B5H) ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:62032-150-10 1 in 1 CARTON 12/01/2019 1 85 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 12/01/2019 Labeler - Obagi Cosmeceuticals LLC (790553353) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 MANUFACTURE(62032-150)
