Label: SKINLYCIOUS MULTI PROTECTION MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide , zinc oxide cream
- NDC Code(s): 81574-002-01, 81574-002-02
- Packager: Skinlycious Pte Ltd
- Category: HUMAN OTC DRUG LABEL
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 January 17, 2023
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- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
- Keep out of reach of children
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Directions
• Apply liberally 15 minutes before sun exposure.
• Apply to all skin exposed to the sun.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months: ask a doctor.
• 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 10a.m.-2p.m.
- wear long-sleeved shirts, pants, hats and sunglasses. -
Inactive Ingredients
Water, Cyclopentasiloxane, PEG-10 Dimethicone, Hydrogenated Polydecene, Butylene Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogen Dimethicone, Ethylene/Acrylic Acid Copolymer, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Olea Europaea Leaf Extract, Phenoxyethanol, Sodium Chloride, Aluminium Hydroxide, Allantoin, Sodium Citrate, Ethylhexylglycerin.
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INGREDIENTS AND APPEARANCE
SKINLYCIOUS MULTI PROTECTION MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
titanium dioxide , zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81574-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.3 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 13.8 g in 100 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALLANTOIN (UNII: 344S277G0Z) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81574-002-01 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/01/2021 2 NDC:81574-002-02 5 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2021 Labeler - Skinlycious Pte Ltd (595402258) Establishment Name Address ID/FEI Business Operations CHAKS COSMETIC DESIGN & SERVICES PTE LTD 595557596 manufacture(81574-002)