21STAY A THERA SUN BLOCK- octinoxate, zinc oxide, titanium dioxide, octisalate, homosalate cream 
Oracle Cosmetic Co., Ltd.

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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71883-001

Octinoxate 6.00%
Zinc Oxide 5.82%
Titanium Dioxide 5.46%
Octisalate 4.00%
Homosalate 2.00%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours
Sun protection 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months


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 using and ask a doctor if rash occurs.

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

Water, Cyclopentasiloxane, Glycerin, PEG-10 Dimethicone, Dicaprylyl Ether, Polymethyl Methacrylate, Dimethicone, Silica, Disteardimonium Hectorite, Sodium Chloride, Aluminum Hydroxide, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Bis-Ethylhexyloxyphenol, Polymethylsilsesquioxane, Stearic Acid, Fragrance, Phenoxyethanol, Dimethicone/Vinyl DimethiconeCrosspolymer, Sorbitan Sesquioleate, Dimethicone/Methicone Copolymer, Propanediol, Ethylhexylglycerin, Butylene Glycol, Octyldodecanol, Bambusa Vulgaris Extract, Echium Plantagineum Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cardiospermum HalicacabumFlower/Leaf/Vine Extract, Lepidium Meyenii Root Extract, Vitis Vinifera (Grape) Seed Oil, Tocopherol, Vegetable Oil, Camellia Sinensis Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Maltodextrin

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

image description

21STAY A THERA SUN BLOCK 
octinoxate, zinc oxide, titanium dioxide, octisalate, homosalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71883-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION58.2 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE54.6 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CHIA SEED (UNII: NU0OLX06F8)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
BEMOTRIZINOL (UNII: PWZ1720CBH)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
PROPANEDIOL (UNII: 5965N8W85T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)  
LEPIDIUM MEYENII ROOT (UNII: HP7119212T)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CORN OIL (UNII: 8470G57WFM)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SAGE (UNII: 065C5D077J)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71883-001-021 in 1 CARTON11/21/201712/31/2022
1NDC:71883-001-0140 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/21/201712/31/2022
Labeler - Oracle Cosmetic Co., Ltd. (688258270)
Registrant - Oracle Cosmetic Co., Ltd. (688258270)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory 689512611manufacture(71883-001)

Revised: 5/2023
 
Oracle Cosmetic Co., Ltd.