by the beach-guangzhou candy clauds 177 ml

by the beach-guangzhou candy clauds 177 ml
SPL v1
SPL
SPL Set ID 4391728b-dfe8-3ffb-e063-6394a90a240e
Route
topical
Published
Effective Date 2023-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 mg) octocrylene (10 mg) octisalate (5 mg)
Inactive Ingredients
lithium magnesium sodium silicate ethylhexylglycerin glyceryl stearate peg-100 stearate potassium cetyl phosphate sodium phosphate phenoxyethanol dimethiconol (100000 cst) disodium phosphate polyacrylamide (10000 mw) laureth-7 ci 16185 polysorbate 60 elaeis guineensis (palm) oil c13-14 isoparaffin hydroxyethylcellulose ci 60730 propylene glycol ethylhexyl palmitate cetyl alcohol stearyl alcohol xanthan gum aqua dimethicone 1000

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-10-03

Purpose

Sunscreen

Description

Octocrylene (10%) – Sunscreen Octisalate (5%) – Sunscreen Avobenzone (3%) – Sunscreen


Medication Information

Warnings

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer & early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Over-exposure to the sun is a serious health threat.

Do not use on damaged and/or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep infants out of direct sunlight.

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

Re-apply frequently to maintain protection, especially after perspiring, swimming or toweling.

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 value 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

Purpose

Sunscreen

Directions

Shake well. Apply liberally and evenly 15–20 minutes before sun exposure.

Apply to all skin exposed to the sun.

Children under 6 months of age: Ask a doctor.

Re-apply immediately after spending time in the water.

Re-apply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating.

Warning: Reducing this quantity will lower the level of protection significantly.

Other Information

Protect the product in this container from excessive heat or direct sun.

This product helps with UVA & UVB protection.

Inactive Ingredients

AQUA, OCTOCRYLENE, ETHYLHEXYL SALICYLATE (OCTISALATE), PROPYLENE GLYCOL, ETHYLHEXYL PALMITATE, BUTYL METHOXYDIBENZOYLMETHANE (AVOBENZONE), GLYCERYL STEARATE, PEG-100 STEARATE, LITHIUM MAGNESIUM SILICATE, ELAEIS GUINEENSIS (PALM) OIL, PHENOXYETHANOL, STEARYL ALCOHOL, POLYACRYLAMIDE, FRAGRANCE, POTASSIUM CETYL PHOSPHATE, C13-14 ISOPARAFFIN, XANTHAN GUM, DIMETHICONE, CETYL ALCOHOL, LAURETH-7, ELAEIS GUINEENSIS (PALM) KERNEL OIL, ETHYLHEXYLGLYCERIN, HYDROXYETHYLCELLULOSE, DIMETHICONOL, CI 16185, CI 60730, DISODIUM PHOSPHATE, POLYSORBATE 60, SODIUM PHOSPHATE

Description

Octocrylene (10%) – Sunscreen Octisalate (5%) – Sunscreen Avobenzone (3%) – Sunscreen

Use

Helps prevent sunburn

If used with other sun protection measures (see below), helps to decrease the risk of skin cancer and early skin aging caused by the sun

Section 50565-1

Keep out of reach of childeren. Contact a Poison Control Center: This is the emergency contact for accidental overdose or ingestion

Active Ingredient(s)

Octocrylene (10%) – Sunscreen

Octisalate (5%) – Sunscreen

Avobenzone (3%) – Sunscreen

Package Label Principal Display Panel


Structured Label Content

Warnings

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer & early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Over-exposure to the sun is a serious health threat.

Do not use on damaged and/or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep infants out of direct sunlight.

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

Re-apply frequently to maintain protection, especially after perspiring, swimming or toweling.

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 value 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

Purpose

Sunscreen

Directions

Shake well. Apply liberally and evenly 15–20 minutes before sun exposure.

Apply to all skin exposed to the sun.

Children under 6 months of age: Ask a doctor.

Re-apply immediately after spending time in the water.

Re-apply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating.

Warning: Reducing this quantity will lower the level of protection significantly.

Other Information (Other information)

Protect the product in this container from excessive heat or direct sun.

This product helps with UVA & UVB protection.

Inactive Ingredients (Inactive ingredients)

AQUA, OCTOCRYLENE, ETHYLHEXYL SALICYLATE (OCTISALATE), PROPYLENE GLYCOL, ETHYLHEXYL PALMITATE, BUTYL METHOXYDIBENZOYLMETHANE (AVOBENZONE), GLYCERYL STEARATE, PEG-100 STEARATE, LITHIUM MAGNESIUM SILICATE, ELAEIS GUINEENSIS (PALM) OIL, PHENOXYETHANOL, STEARYL ALCOHOL, POLYACRYLAMIDE, FRAGRANCE, POTASSIUM CETYL PHOSPHATE, C13-14 ISOPARAFFIN, XANTHAN GUM, DIMETHICONE, CETYL ALCOHOL, LAURETH-7, ELAEIS GUINEENSIS (PALM) KERNEL OIL, ETHYLHEXYLGLYCERIN, HYDROXYETHYLCELLULOSE, DIMETHICONOL, CI 16185, CI 60730, DISODIUM PHOSPHATE, POLYSORBATE 60, SODIUM PHOSPHATE

Use

Helps prevent sunburn

If used with other sun protection measures (see below), helps to decrease the risk of skin cancer and early skin aging caused by the sun

Section 50565-1 (50565-1)

Keep out of reach of childeren. Contact a Poison Control Center: This is the emergency contact for accidental overdose or ingestion

Active Ingredient(s)

Octocrylene (10%) – Sunscreen

Octisalate (5%) – Sunscreen

Avobenzone (3%) – Sunscreen

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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