Label: ONESKIN OS-01 SHIELD BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN TINTED- zinc oxide cream
- NDC Code(s): 62742-4228-1, 62742-4228-2
- Packager: Allure Labs
- 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 August 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
Direction-
Apply liberally 15 minutes before sun exposure.
Reapply at least every two hours.
Use a water-resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor.
Sun protection measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad-spectrum value of 15 or higher and other sun protection measures including:
Limit time in the sun. especially from 10 am to 2 pm
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, CI77499)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ONESKIN OS-01 SHIELD BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN TINTED
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4228 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 PEPTIDE-T (UNII: 05DYM3ZS1X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) COCO GLUCOSIDE (UNII: ICS790225B) LEVOMENOL (UNII: 24WE03BX2T) STARCH, RICE (UNII: 4DGK8B7I3S) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SORBITAN OLIVATE (UNII: MDL271E3GR) ETHYL FERULATE (UNII: 5B8915UELW) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SHEANUT (UNII: 84H6HBP32L) HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62) WATER (UNII: 059QF0KO0R) CETYL PALMITATE (UNII: 5ZA2S6B08X) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) ACAI (UNII: 46AM2VJ0AW) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PHYTATE SODIUM (UNII: 88496G1ERL) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) FERRIC OXIDE RED (UNII: 1K09F3G675) SODIUM BENZOATE (UNII: OJ245FE5EU) ACACIA (UNII: 5C5403N26O) ISOSTEARIC ACID (UNII: X33R8U0062) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) ALLANTOIN (UNII: 344S277G0Z) ALUMINUM OXIDE (UNII: LMI26O6933) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4228-2 1 in 1 CARTON 08/14/2023 1 NDC:62742-4228-1 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 final M020 08/14/2023 Labeler - Allure Labs (926831603) Registrant - Allure Labs (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4228)
