ONESKIN OS-01 SHIELD BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN TINTED- zinc oxide cream 
Allure Labs

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.

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Drug Facts

Active ingredients – Zinc Oxide 17.5 %

Purpose – Sunscreen

Uses –

Helps prevent sunburn
If used as directed with other sun protection measures (See direction), decreases the risk of skin cancer and early skin aging caused by the sun.

Warning – For external use only

Do not use on damaged or broken skin

When using this product keep out of eye. Rinse with water to remove.

Stop use and ask doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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 information:

Protect the product in this container from excessive heat and direct sun.

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)

OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted.

ONESKIN OS-01 SHIELD BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN TINTED 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4228
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4228-21 in 1 CARTON08/14/2023
1NDC:62742-4228-140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02008/14/2023
Labeler - Allure Labs (926831603)
Registrant - Allure Labs (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs926831603manufacture(62742-4228)

Revised: 8/2023
Document Id: 02e7fb00-203a-c4f8-e063-6294a90a418f
Set id: 02e7fb00-2039-c4f8-e063-6294a90a418f
Version: 1
Effective Time: 20230814
 
Allure Labs