Coco &

Coco &
SPL v1
SPL
SPL Set ID 1812bed2-fbde-4acf-850d-9d0d193fbf7f
Route
TOPICAL
Published
Effective Date 2024-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (15 g) Octocrylene (10 g) Octisalate (5 g) Avobenzone (3 g)
Inactive Ingredients
Ethylhexyl Palmitate Diethylhexyl 2,6-naphthalate Butyloctyl Salicylate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Polyamide-8 (4500 Mw) Isopropyl Palmitate Diethylhexyl Syringylidenemalonate Sunflower Oil Soybean Lecithin Ethyl Vanillin Octahydrocoumarin Piperonal Ethyl Maltol Sandalore Hexyl Salicylate 6,6-dimethoxy-2,5,5-trimethyl-2-hexene Ethyl Linalool Isocyclemone E Butylated Hydroxytoluene Hexamethylindanopyran Methyl 2-nonynoate Apricot Kernel Oil Watermelon Seed Oil Tocopherol Guava Pineapple Cocoa Acetyl Hexapeptide-1 Medium-chain Triglycerides Vanillin Tetramethyl Acetyloctahydronaphthalenes .alpha.-damascone, (e)- .delta.-damascone .beta.-damascenone Water

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-22

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

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.
Dosage and Administration

Directions

  • Apply 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 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-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other Information

Protect the product from excessive heat and direct sun.

Questions? Contact (626) 616-5811

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

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.

Section 55105-1

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Section 55106-9

Active Ingredients

Homosalate 15%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

Principal Display Panel

COCO & EVE

TAN BOOSTING ANTI-AGING

BODY OIL SPF 40

High Protection

UVA + UVB

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net 150 mL / e 5.07 fl. oz. US

SPF

40

COCO & EVE

SUNNY

HONEY

TAN BOOSTING ANTI-AGING

BODY OIL SPF 40

High Protection

UVA + UVB

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Tanning Peptides

Net 150 mL / e 5.07 fl. oz. US


Structured Label Content

Indications and Usage (34067-9)

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.
Dosage and Administration (34068-7)

Directions

  • Apply 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 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-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.
Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other Information

Protect the product from excessive heat and direct sun.

Questions? Contact (626) 616-5811

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51727-6 (51727-6)

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.

Section 55105-1 (55105-1)

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Homosalate 15%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COCO & EVE

TAN BOOSTING ANTI-AGING

BODY OIL SPF 40

High Protection

UVA + UVB

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net 150 mL / e 5.07 fl. oz. US

SPF

40

COCO & EVE

SUNNY

HONEY

TAN BOOSTING ANTI-AGING

BODY OIL SPF 40

High Protection

UVA + UVB

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Tanning Peptides

Net 150 mL / e 5.07 fl. oz. US


Advanced Ingredient Data


Raw Label Data

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