Label: SKINCEUTICALS PHYSICAL EYE UV DEFENSE SUNSCREEN- titanium dioxide and zinc oxide lotion
- NDC Code(s): 49967-050-01, 49967-050-02
- Packager: L'Oreal USA Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 28, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
For sunscreen use:
● apply liberally 15 minutes before sun exposure
● reapply at least every 2 hours
● use a water resistant sunscreen if swimming or sweating
● 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 of age: Ask a doctor
- Other information
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Inactive ingredients
dimethicone, C12-15 alkyl benzoate, triethylhexanoin, isohexadecane, talc, hydrogentated jojoba oil, dimethicone crosspolymer, styrene/acrylates copolymer, C30-45 alkyldimethylsilyl polypropylsilsesquioxane, dimethicone/vinyl dimethicone crosspolymer aluminum stearate, alumina, polyhydroxystearic acid, iron oxides, phenoxyethanol, silica silylate, PEG-8 laurate, triethoxycaprylylsilane, 2-oleamido-1,3-octadecanediol, disodium stearoyl glutamate, paraffin, aluminum hydroxide
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INGREDIENTS AND APPEARANCE
SKINCEUTICALS PHYSICAL EYE UV DEFENSE SUNSCREEN
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 90 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ISOHEXADECANE (UNII: 918X1OUF1E) TALC (UNII: 7SEV7J4R1U) HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) ALUMINUM OXIDE (UNII: LMI26O6933) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) FERRIC OXIDE RED (UNII: 1K09F3G675) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-8 LAURATE (UNII: 762O8IWA10) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 9-OCTADECENAMIDE, N-(2-HYDROXY-1-(HYDROXYMETHYL)HEPTADECYL)-, (9Z)- (UNII: 30D478BUNR) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) PARAFFIN (UNII: I9O0E3H2ZE) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-050-01 1 in 1 CARTON 04/18/2014 07/27/2026 1 10 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-050-02 0.15 mL in 1 PACKET; Type 0: Not a Combination Product 04/18/2014 07/27/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/18/2014 07/27/2026 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Goodier Cosmetics LP 007317209 manufacture(49967-050) Establishment Name Address ID/FEI Business Operations Beauty Manufacturing Solutions Corp. 783200723 manufacture(49967-050)