Coconut Milk Body Spf 50 (85624-002-20)

Coconut Milk Body Spf 50 (85624-002-20)
SPL v1
SPL
SPL Set ID 3d4d1b94-b1ce-cf94-e063-6394a90a61ba
Route
TOPICAL
Published
Effective Date 2025-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Avobenzone (3 g) Octocrylene (10 g) Homosalate (15 g)
Inactive Ingredients
Water Phenoxyethanol Lauryl Glucoside Propanediol Carica Papaya (papaya) Fruit Sodium Metabisulfite Myristyl Glucoside Cocos Nucifera (coconut) Fruit Diisopropyl Adipate Polyglyceryl-3 Methylglucose Distearate Polyester-7 Tocopherol Tetrasodium Glutamate Diacetate Glycerin Sodium Hydroxide Potassium Sorbate Microcrystalline Cellulose Helianthus Annuus (sunflower) Seed Oil Silica Sodium Citrate Butyloctyl Salicylate Polyglyceryl-6 Laurate Saccharide Isomerate Sodium Stearoyl Glutamate Diethylhexyl Syringylidenemalonate Cellulose Gum Ethylhexylglycerin Caprylic/capric Triglyceride Ananas Sativus (pineapple) Fruit Citrullus Lanatus (watermelon) Seed Oil Hylocereus Undatus Fruit Citric Acid Mangifera Indica (mango) Fruit Propylene Glycol Dibenzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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.

Section 51945-4

Warnings

For external use only

Directions

• Shake well before use. Apply generously all over the 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 ever 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 sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

• Children under 6 months: ask a doctor.

Do Not Use

on damaged skin or broken skin

Drug Facts

Drug Facts

Questions?

Contact (609) 320-4845

Other Information

Protect the product from excessive heat and direct sun.

Active Ingredients

Homosalate 15%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

Inactive Ingredients

AQUA (WATER, EAU), BUTYLOCTYL SALICYLATE, SILICA, PROPANEDIOL, DIISOPROPYL ADIPATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, POLYESTER-7, LAURYL GLUCOSIDE, MICROCRYSTALLINE CELLULOSE, POLYGLYCERYL-6 LAURATE, PHENOXYETHANOL, PROPYLENE GLYCOL DIBENZOATE, SACCHARIDE ISOMERATE, PARFUM (FRAGRANCE), 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 FRUIT EXTRACT, SODIUM HYDROXIDE, POTASSIUM SORBATE, SODIUM METABISULFITE.

When Using This Product

keep out of eyes. Rince 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.


Structured Label Content

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.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

• Shake well before use. Apply generously all over the 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 ever 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 sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

• Children under 6 months: ask a doctor.

Do Not Use (Do not use)

on damaged skin or broken skin

Drug Facts

Drug Facts

Questions?

Contact (609) 320-4845

Other Information (Other information)

Protect the product from excessive heat and direct sun.

Active Ingredients (Active ingredients)

Homosalate 15%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

Inactive Ingredients (Inactive ingredients)

AQUA (WATER, EAU), BUTYLOCTYL SALICYLATE, SILICA, PROPANEDIOL, DIISOPROPYL ADIPATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, POLYESTER-7, LAURYL GLUCOSIDE, MICROCRYSTALLINE CELLULOSE, POLYGLYCERYL-6 LAURATE, PHENOXYETHANOL, PROPYLENE GLYCOL DIBENZOATE, SACCHARIDE ISOMERATE, PARFUM (FRAGRANCE), 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 FRUIT EXTRACT, SODIUM HYDROXIDE, POTASSIUM SORBATE, SODIUM METABISULFITE.

When Using This Product (When using this product)

keep out of eyes. Rince with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a 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.


Advanced Ingredient Data


Raw Label Data

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