equate sunscreen mineral based kids broad spectrum spf 50

equate sunscreen mineral based kids broad spectrum spf 50
SPL v4
SPL
SPL Set ID 0cdfc3a1-4bfa-474d-a4eb-4bfa1e628c89
Route
topical
Published
Effective Date 2022-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (50 mg) octocrylene (100 mg) zinc cation (150 mg)
Inactive Ingredients
medium-chain triglycerides cocoa butter lauryl laurate alkyl (c12-15) benzoate tridecyl salicylate synthetic beeswax ceresin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-03-26

Purpose

Sunscreen

Description

Homosalate 5.0%, Octocrylene 10.0%, Zinc Oxide 15.0%


Medication Information

Warnings

For external use only

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

Purpose

Sunscreen

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months of age: Ask a doctor

• 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

Other Information

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

caprylic/capric triglyceride, ozokerite, theobroma cacao (cocoa) seed butter, tridecyl salicylate, lauryl laurate bis-PEG-12 dimethicone beeswax, C12-15 alkyl benzoate, synthetic beeswax

Description

Homosalate 5.0%, Octocrylene 10.0%, Zinc Oxide 15.0%

Label

Do Not Use

•on damaged or broken skin.

Active Ingredients

Homosalate 5.0%,

Octocrylene 10.0%,

Zinc Oxide 15.0%

When Using This Product

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

• rash occurs.

Keep Out of Reach of Children

If product is swallowed, get medical help or contact a Poison Control Poison Control Center right away.


Structured Label Content

Warnings

For external use only

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

Purpose

Sunscreen

Directions

• apply liberally 15 minutes before sun exposure

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

• children under 6 months of age: Ask a doctor

• 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

Other Information (Other information)

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients (Inactive ingredients)

caprylic/capric triglyceride, ozokerite, theobroma cacao (cocoa) seed butter, tridecyl salicylate, lauryl laurate bis-PEG-12 dimethicone beeswax, C12-15 alkyl benzoate, synthetic beeswax

Label

Do Not Use (Do not use)

•on damaged or broken skin.

Active Ingredients (Active ingredients)

Homosalate 5.0%,

Octocrylene 10.0%,

Zinc Oxide 15.0%

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash occurs.

Keep Out of Reach of Children (Keep out of reach of children)

If product is swallowed, get medical help or contact a Poison Control Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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