Coco &

Coco &
SPL v1
SPL
SPL Set ID 15fc4643-bfbb-4664-bc5a-eb625fa22bde
Route
TOPICAL
Published
Effective Date 2023-11-16
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 Alkyl (c12-15) Benzoate Dibutyl Adipate Diethylhexyl Sebacate Butyloctyl Salicylate Isopropyl Palmitate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Vinylpyrrolidone/eicosene Copolymer C13-15 Alkane Diethylhexyl Syringylidenemalonate Lecithin, Soybean Sunflower 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 Watermelon Seed Oil Apricot Kernel Oil Tocopherol Water Medium-chain Triglycerides Pineapple Guava Cocoa Acetyl Hexapeptide-1

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
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours.
  • 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, C12-15 Alkyl Benzoate, Dibutyl Adipate, Diethylhexyl Sebacate, Butyloctyl Salicylate, Isopropyl Palmitate, Polyester-8, VP/Eicosene Copolymer, C13-15 Alkane, Diethylhexyl Syringylidenemalonate, Lecithin, Helianthus Annuus (Sunflower) Seed Oil, Fragrance, Citrullus Lanatus (Watermelon) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Tocopherol, Water, Caprylic/Capric Triglyceride, Ananas Sativus (Pineapple) Fruit Extract, Psidium Guajava Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Acetyl Hexapeptide-1.

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients

Homosalate 15%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

Principal Display Panel

COCO & EVE

SUNNY

HONEY

TAN BOOSTING ANTI-AGING

BODY OIL SPF 30

UVA + UVB

Broad Spectrum SPF 30

Water Resistant (40 minutes)

Tanning Peptides

Net 150 mL / e 5.07 fl. oz. US

COCO & EVE

SUNNY

HONEY

TAN BOOSTING ANTI-AGING

BODY OIL SPF 30

UVA + UVB

Broad Spectrum SPF 30

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.
  • 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
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours.
  • 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, C12-15 Alkyl Benzoate, Dibutyl Adipate, Diethylhexyl Sebacate, Butyloctyl Salicylate, Isopropyl Palmitate, Polyester-8, VP/Eicosene Copolymer, C13-15 Alkane, Diethylhexyl Syringylidenemalonate, Lecithin, Helianthus Annuus (Sunflower) Seed Oil, Fragrance, Citrullus Lanatus (Watermelon) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, Tocopherol, Water, Caprylic/Capric Triglyceride, Ananas Sativus (Pineapple) Fruit Extract, Psidium Guajava Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Acetyl Hexapeptide-1.

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Homosalate 15%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COCO & EVE

SUNNY

HONEY

TAN BOOSTING ANTI-AGING

BODY OIL SPF 30

UVA + UVB

Broad Spectrum SPF 30

Water Resistant (40 minutes)

Tanning Peptides

Net 150 mL / e 5.07 fl. oz. US

COCO & EVE

SUNNY

HONEY

TAN BOOSTING ANTI-AGING

BODY OIL SPF 30

UVA + UVB

Broad Spectrum SPF 30

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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