OS-01 FACE SPF BS SPF30 TINTED- zinc oxide cream

OS-01 Face SPF BS SPF30 Tinted by

Drug Labeling and Warnings

OS-01 Face SPF BS SPF30 Tinted by is a Otc medication manufactured, distributed, or labeled by ONESKIN INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients – Zinc Oxide 17.5 %

PURPOSE

Purpose – Sunscreen

INDICATIONS & USAGE

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.

WARNINGS

Warning – For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

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

Other information:

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

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

INGREDIENTS AND APPEARANCE

OS-01 FACE SPF BS SPF30 TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84451-002
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)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ETHYL FERULATE (UNII: 5B8915UELW)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)
WATER (UNII: 059QF0KO0R)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
SHEANUT (UNII: 84H6HBP32L)
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)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHYTATE SODIUM (UNII: 88496G1ERL)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ACACIA (UNII: 5C5403N26O)
ISOSTEARIC ACID (UNII: X33R8U0062)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM BENZOATE (UNII: OJ245FE5EU)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
ALLANTOIN (UNII: 344S277G0Z)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84451-002-02	1 in 1 CARTON	09/13/2023
1	NDC: 84451-002-01	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 Drug	M020	09/13/2023

Labeler - ONESKIN INC. (088037418)