COCO-EVE COCONUT MILK BODY SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

COCO-EVE COCONUT MILK BODY SPF 50 by

Drug Labeling and Warnings

COCO-EVE COCONUT MILK BODY SPF 50 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Homosalate 15%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

PURPOSE

Purpose

Sunscreen

USES

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

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

Directions

• Apply generously all over the body 20 minutes before sun exposure, ensuring every part of the body is convered. Reapply at least every 2 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 or 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butyloctyl Salicylate, Silica, Diisopropyl Adipate, Propanediol, Polyglyceryl-3 Methylglucose Distearate, Polyester-7, Lauryl Glucoside, Microcrystalline Cellulose, Polyglyceryl-6 Laurate, Phenoxyethanol, Neopentyl Glycol Diheptanoate, Saccharide Isomerate, Fragrance (Parfum), Myristyl Glucoside, Sodium Stearoyl Glutamate, Diethylhexyl Syringylidenemalonate, Cellulose Gum, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Ethylhexylglycerin, Tetrasodium Glutamate Diacetate, Glycerin, Caprylic/Capric Triglyceride, Ananas Sativus (Pineapple) Fruit Extract, Citrullus Lanatus (Watermelon) Seed Oil, Hylocereus Undatus Fruit Extract, Citric Acid, Sodium Citrate, Carica Papaya (Papaya) Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Sodium Hydroxide, Potassium Sorbate, Sodium Metabisulfite.

OTHER INFORMATION

Other Information

Protect the product from excessive heat and direct sun.

QUESTIONS?

Questions? Contact (609) 320-4845

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COCO-EVE COCONUT MILK BODY SPF 50 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-243
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
CITRULLUS LANATUS (WATERMELON) SEED OIL (UNII: L33J06UQTT)
HYLOCEREUS UNDATUS FRUIT (UNII: WUG58TD53X)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
PROPANEDIOL (UNII: 5965N8W85T)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)
CELLULOSE GUM (UNII: K679OBS311)
ANANAS SATIVUS (PINEAPPLE) FRUIT (UNII: 2A88ZO081O)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SILICA (UNII: ETJ7Z6XBU4)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)
POLYESTER-7 (UNII: 0841698D2F)
POLYGLYCERYL-6 LAURATE (UNII: Q48X4BL3TV)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARICA PAPAYA (PAPAYA) FRUIT (UNII: KU94FIY6JB)
COCOS NUCIFERA (COCONUT) FRUIT (UNII: 3RT3536DHY)
MANGIFERA INDICA (MANGO) FRUIT (UNII: I629I3NR86)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-243-01	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/06/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/06/2026

Labeler - COSMAX USA (010990210)

Registrant - COSMAX USA (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA		010990210	manufacture(68577-243)