COCO AND EVE TAN BOOSTING ANTI AGING BODY OIL SPF 45- homosalate, octocrylene, octisalate, avobenzone oil

Coco and Eve Tan Boosting Anti Aging Body Oil SPF 45 by

Drug Labeling and Warnings

Coco and Eve Tan Boosting Anti Aging Body Oil SPF 45 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORP. 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.

Do not stay too long in the sun, even while using a sunscreen product.

Keep babies and young children out of direct sunlight.

Over-exposure to the sun i serious health threat

DIRECTIONS

Directions

• Appply generously an even layer all over body 20 minutes before sun exposure, ensuring every part of the body is covered. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 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 broad-spectrum SPF of 15 or higher and other sun protection measures including.
• Limit time in the sun especially from 10 a.m.-2p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months:ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

Ethylhexyl Palmitate, Diethylhexyl 2,6-Naphthalate, Butyloctyl Salicylate, Polyester-8, Polyamide-8, Isopropyl Palmitate, Diethylhexyl Syringylidenemalonate, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Fragrance, Prunus Armeniaca (Apricot) Kernel Oil, Citrullus Lanatus (Watermelon) Seed Oil, Tocopherol, Psidium Guajava Fruit Extract, Ananas Sativus (Pineapple) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Acetyl Hexapeptide-1, Caprylic/Capric Triglyceride, Vanillin, Tetramethyl Acetyloctahydronaphthalenes, Rose Ketones, Water.

OTHER INFORMATION

Other Information

Protect the product from excessive heat and direct sun.

QUESTIONS

Questions?

Contact (626) 616-5811

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COCO AND EVE TAN BOOSTING ANTI AGING BODY OIL SPF 45 
homosalate, octocrylene, octisalate, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-222
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
THEOBROMA CACAO (COCOA) SEED POWDER (UNII: D9108TZ9KG)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE (UNII: 255PIF62MS)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
WATER (UNII: 059QF0KO0R)
PSIDIUM GUAJAVA FRUIT (UNII: 74O70D6VG0)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
TOCOPHEROL (UNII: R0ZB2556P8)
ANANAS SATIVUS (PINEAPPLE) FRUIT (UNII: 2A88ZO081O)
ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ)
CITRULLUS LANATUS (WATERMELON) SEED OIL (UNII: L33J06UQTT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-222-01	1 in 1 CARTON	10/01/2025
1		158 mL in 1 BOTTLE; 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	10/01/2025

Labeler - COSMAX USA, CORP (010990210)

Registrant - COSMAX USA, CORP (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA, CORP		010990210	manufacture(68577-222)