ONESKIN OS-01 SHIELD BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN UNTINTED- 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.

----------

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.

OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Untinted

ONESKIN OS-01 SHIELD BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN UNTINTED 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4229
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
GLYCERIN (UNII: PDC6A3C0OX)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
ALLANTOIN (UNII: 344S277G0Z)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
STARCH, RICE (UNII: 4DGK8B7I3S)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
SHEANUT (UNII: 84H6HBP32L)  
LEVOMENOL (UNII: 24WE03BX2T)  
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
ACACIA (UNII: 5C5403N26O)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEPTIDE-T (UNII: 05DYM3ZS1X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
COCO GLUCOSIDE (UNII: ICS790225B)  
ETHYL FERULATE (UNII: 5B8915UELW)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ACAI (UNII: 46AM2VJ0AW)  
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4229-21 in 1 CARTON08/15/2023
1NDC:62742-4229-140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02008/15/2023
Labeler - Allure Labs (926831603)
Registrant - Allure Labs (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs926831603manufacture(62742-4229)

Revised: 8/2023
Document Id: 02f9c859-8d7e-5146-e063-6394a90a57b5
Set id: 02f9c859-8d7d-5146-e063-6394a90a57b5
Version: 1
Effective Time: 20230815
 
Allure Labs