Label: SKINCEUTICALS PHYSICAL UV DEFENSE BROAD SPECTRUM SPF 30 SUNSCREEN- titanium dioxide and zinc oxide cream
- NDC Code(s): 49967-472-01, 49967-472-02
- 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.
-
Directions
● shake well before 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
-
Inactive ingredients
water, glycerin, c12-15 alkyl benzoate, dimethicone, butyloctyl salicylate, phenethyl benzoate, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, stearyl dimethicone, butyrospermum parkii (shea) butter, isododecane, polyglyceryl-4 isostearate, talc, dimethicone/polyglycerin-3 crosspolymer, nylon-12, pentylene glycol, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, aluminum stearate, phenoxyethanol, alumina, polyhydroxystearic acid, magnesium sulfate, caprylyl glycol, PEG-8 laurate, disteardimonium hectorite, triethoxycaprylylsilane, tocopherol, propylene carbonate, artemia extract, benzoic acid, dipropylene glycol, sodium hyaluronate
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SKINCEUTICALS PHYSICAL UV DEFENSE BROAD SPECTRUM SPF 30 SUNSCREEN
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-472 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 50 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PHENETHYL BENZOATE (UNII: 0C143929GK) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) ISOHEXADECANE (UNII: 918X1OUF1E) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) STEARYL TRISILOXANE (UNII: 796MG354ZZ) SHEA BUTTER (UNII: K49155WL9Y) ISODODECANE (UNII: A8289P68Y2) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) TALC (UNII: 7SEV7J4R1U) NYLON-12 (UNII: 446U8J075B) PENTYLENE GLYCOL (UNII: 50C1307PZG) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) ALUMINUM STEARATE (UNII: U6XF9NP8HM) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM OXIDE (UNII: LMI26O6933) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PEG-8 LAURATE (UNII: 762O8IWA10) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TOCOPHEROL (UNII: R0ZB2556P8) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ARNICA MONTANA (UNII: O80TY208ZW) BENZOIC ACID (UNII: 8SKN0B0MIM) DIPROPYLENE GLYCOL (UNII: E107L85C40) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-472-01 1 in 1 CARTON 01/01/2012 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49967-472-02 4 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/01/2012 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Cosmetic Essence, LLC 032565959 manufacture(49967-472) Establishment Name Address ID/FEI Business Operations Goodier Cosmetics LP 007317209 manufacture(49967-472)