OS-01 FACE SPF BS SPF 30 TINTED DEEP- zinc oxide cream 
ONESKIN INC.

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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 Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 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, CI 77499)

OS-01 Face SPF BS SPF30 Tinted Deep

OS-01 FACE SPF BS SPF 30 TINTED DEEP 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84451-005
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84451-005-021 in 1 CARTON05/12/2025
1NDC:84451-005-0140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/12/2025
Labeler - ONESKIN INC. (088037418)

Revised: 5/2025
Document Id: 3581efdc-41fa-a450-e063-6294a90a4e56
Set id: 3581f578-e19e-9ace-e063-6294a90acc34
Version: 1
Effective Time: 20250519
 
ONESKIN INC.