Coco &

Coco &
SPL v1
SPL
SPL Set ID 1b1644ce-d2de-44b7-b86a-a6e96ccc8ba8
Route
TOPICAL
Published
Effective Date 2023-12-05
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 Vinylpyrrolidone/eicosene Copolymer Isopropyl Palmitate Medium-chain Triglycerides C13-15 Alkane Coco-caprylate Apricot Kernel Oil Sunflower Oil Tocopherol Diethylhexyl Syringylidenemalonate Lecithin, Soybean Watermelon Seed Oil Ethyl Vanillin Vanillin Octahydrocoumarin Piperonal Ethyl Maltol Sandalore Hexyl Salicylate 6,6-dimethoxy-2,5,5-trimethyl-2-hexene Ethyl Linalool Isocyclemone E Butylated Hydroxytoluene .delta.-damascone Hexamethylindanopyran .beta.-damascenone Methyl 2-nonynoate Guava Pineapple Cocoa Acetyl Hexapeptide-1 Water

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only.

Store below 30°C / 86°F and avoid direct sunlight.

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.
  • 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.
  • Reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating.
  • 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. When using this product keep out of eyes. Rinse with water to remove.

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, VP/Eicosene Copolymer, Isopropyl Palmitate, Caprylic/Capric Triglyceride, Coco-Caprylate, C13-15 Alkane, Prunus Armeniaca (Apricot) Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Citrullus Lanatus (Watermelon) Seed Oil, Psidium Guajava Fruit Extract, Ananas Sativus (Pineapple) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Acetyl Hexapeptide-1, Tocopherol, Lecithin, Diethylhexyl Syringylidenemalonate, Fragrance, 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 20

UVA + UVB

Broad Spectrum SPF 20

Tanning Peptides

Net 150 mL / e 5.07 fl. oz. US

COCO & EVE

SUNNY

HONEY

TAN BOOSTING ANTI-AGING

BODY OIL SPF 20

UVA + UVB

Broad Spectrum SPF 20

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.
  • 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.
  • Reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months: ask a doctor.
Warnings and Precautions (34071-1)

Warnings

For external use only.

Store below 30°C / 86°F and avoid direct sunlight.

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. When using this product keep out of eyes. Rinse with water to remove.

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, VP/Eicosene Copolymer, Isopropyl Palmitate, Caprylic/Capric Triglyceride, Coco-Caprylate, C13-15 Alkane, Prunus Armeniaca (Apricot) Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Citrullus Lanatus (Watermelon) Seed Oil, Psidium Guajava Fruit Extract, Ananas Sativus (Pineapple) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Acetyl Hexapeptide-1, Tocopherol, Lecithin, Diethylhexyl Syringylidenemalonate, Fragrance, 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 20

UVA + UVB

Broad Spectrum SPF 20

Tanning Peptides

Net 150 mL / e 5.07 fl. oz. US

COCO & EVE

SUNNY

HONEY

TAN BOOSTING ANTI-AGING

BODY OIL SPF 20

UVA + UVB

Broad Spectrum SPF 20

Tanning Peptides

Net 150 mL / e 5.07 fl. oz. US


Advanced Ingredient Data


Raw Label Data

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