FULLY RICE CERAMIDE MOISTURE SUNSCREEN- zinc oxide cream

FULLY RICE CERAMIDE MOISTURE SUNSCREEN by

Drug Labeling and Warnings

FULLY RICE CERAMIDE MOISTURE SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Adapt Inc., Kolmar Korea Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

ACTIVE INGREDIENT

Avobenzone 2.7%

Homosalate 13.6%

Octisalate 4.5%

Octocrylene 9.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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 using and ask a doctor if rash occurs.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

Use a water-resistant sunscreen if swimming or sweating

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 or higher and other sun protection measures including: - Limit time in the sun, especially from 10 am to 2 pm. - Wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENT

WATER, BUTYLOCTYL SALICYLATE, PROPANEDIOL, C20-22 ALKYL PHOSPHATE, SILICA, POLYMETHYLSILSESQUIOXANE, C20-22 ALCOHOLS, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, PANTHENOL, METHYL TRIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, GLYCERYL STEARATE, VP/EICOSENE COPOLYMER, TROMETHAMINE, POLYACRYLATE CROSSPOLYMER-6, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, BUTYLENE GLYCOL, ETHYLHEXYLGLYCERIN, METHYLPROPANEDIOL, POLYETHER-1, CERAMIDE NP, ORYZA SATIVA (RICE) BRAN OIL, TOCOPHEROL, ORYZA SATIVA (RICE) BRAN WATER, BIOSACCHARIDE GUM-1

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FULLY RICE CERAMIDE MOISTURE SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87343-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	136 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PROPANEDIOL (UNII: 5965N8W85T)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PANTHENOL (UNII: WV9CM0O67Z)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
TROMETHAMINE (UNII: 023C2WHX2V)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYETHER-1 (2800 MPA.S) (UNII: 6QR7NJP3G8)
CERAMIDE NP (UNII: 4370DF050B)
RICE BRAN OIL (UNII: LZO6K1506A)
TOCOPHEROL (UNII: R0ZB2556P8)
RICE BRAN, DEFATTED (UNII: H6597RO5A2)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87343-001-02	1 in 1 CARTON	02/23/2026
1	NDC: 87343-001-01	50 mL 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	02/23/2026

Labeler - Adapt Inc. (694865012)

Registrant - Adapt Inc. (694865012)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd		963271745	manufacture(87343-001)