OS-01 BODY SPF 30- zinc oxide cream

OS-01 Body SPF 30 by

Drug Labeling and Warnings

OS-01 Body SPF 30 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 14 %

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 after 80 minutes of swimming or sweating.
immediately after towel drying, at least every 2 hours
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

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

INACTIVE INGREDIENT

Inactive Ingredients: Caprylic/Capric Triglyceride 40 - 65 Butyloctyl Salicylate, C13-15 Alkane, Stearalkonium Hectorite,Coconut Alkanes, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Wax, Propylene Carbonate, Quaternium-90 Bentonite, Butyrospermum Parkii Nut Extract, Decapeptide-52, Camellia Oleifera (Tea) Seed Oil, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Aloe Barbadensis Leaf Extract, Carthamus Tinctorius Seed Oil, Lactobacillus/Acerola Cherry Ferment, Coco-Caprylate/Caprate, Ceramide NP, Ceramide AP, Ceramide EOP, Ethylhexylglycerin, Caprylyl Glycol, Hexylene Glycol, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Lecithin, Phytosphingosine, Cholesterol, Sodium lauroyl lactylate , Carbomer, Xanthan gum, Water, Propylene Glycol ,Triethyl Citrate, Citric Acid, Sodium Benzoate, Phenoxyethanol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OS-01 BODY SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84451-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I)
CANDELILLA WAX (UNII: WL0328HX19)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SHEANUT (UNII: 84H6HBP32L)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
SAFFLOWER OIL (UNII: 65UEH262IS)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)
CAMELLIA OIL (UNII: T1PE06G0VE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MALPIGHIA EMARGINATA SEED (UNII: 1X7L93686M)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CHOLESTEROL (UNII: 97C5T2UQ7J)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
C13-15 ALKANE (UNII: 114P5I43UJ)
COCONUT ALKANES (UNII: 1E5KJY107T)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84451-001-02	1 in 1 CARTON	06/20/2024
1	NDC: 84451-001-01	100 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	06/20/2024

Labeler - ONESKIN, INC (088037418)