Label: OS-01 FACE SPF BS SPF 30 TINTED DEEP- zinc oxide cream
- NDC Code(s): 84451-005-01, 84451-005-02
- Packager: ONESKIN INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 19, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours
Use a water-resistant sunscreen If swimming or sweating.
Children under 6 months of age: Ask a Doctor.
Sun Probation 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 SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients
Water (Aqua),Caprylic/Capric Triglyceride, Glycerin, Methyl Dihydroabietate, Cetearyl Alcohol, Cetyl Palmitate, Coco-Glucoside, Caprylyl/Capryl Glucoside, Sorbitan Palmitate, Sorbitan Olivate, Butyrospermum Parkii (Shea) Nut Extract, Ethyl Ferulate, Bisabolol, Allantoin, Hydrolyzed Jojoba Esters, Acacia Senegal Gum, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Lecithin, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Decapeptide-52*,Oryza Sativa (Rice) Starch, Camellia Sinensis Leaf Extract, Euterpe Oleracea Fruit Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Xanthan Gum, Sodium Phytate, Propylene Glycol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Triethoxycaprylylsilane, Alumina, Magnesium Oxide, Iron Oxides (CI 77491, CI 77492, CI 77499) - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OS-01 FACE SPF BS SPF 30 TINTED DEEP
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84451-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17.5 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITAN PALMITATE (UNII: 77K6Z421KU) SODIUM PHYTATE (UNII: 88496G1ERL) BISABOLOL (UNII: 24WE03BX2T) CETYL PALMITATE (UNII: 5ZA2S6B08X) COCO GLUCOSIDE (UNII: ICS790225B) CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0) XANTHAN GUM (UNII: TTV12P4NEE) CETEARYL ALCOHOL (UNII: 2DMT128M1S) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) CAPRYLYL/CAPRYL GLUCOSIDE (UNII: E00JL9G9K0) ACACIA SENEGAL GUM (UNII: 5C5403N26O) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) CI 77499 (UNII: XM0M87F357) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) CI 77491 (UNII: 1K09F3G675) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ETHYL FERULATE (UNII: 5B8915UELW) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) ORYZA SATIVA (RICE) STARCH (UNII: 4DGK8B7I3S) PHENOXYETHANOL (UNII: HIE492ZZ3T) CI 77492 (UNII: EX438O2MRT) SORBITAN OLIVATE (UNII: MDL271E3GR) SHEANUT (UNII: 84H6HBP32L) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) ALLANTOIN (UNII: 344S277G0Z) HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ISOSTEARIC ACID (UNII: X33R8U0062) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) ACAI (UNII: 46AM2VJ0AW) ALUMINA (UNII: LMI26O6933) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84451-005-02 1 in 1 CARTON 05/12/2025 1 NDC:84451-005-01 40 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 Drug M020 05/12/2025 Labeler - ONESKIN INC. (088037418)

