kids spf 50 sunscreen lotion

kids spf 50 sunscreen lotion
SPL v1
SPL
SPL Set ID fc64e2a9-d75e-4b54-a31a-785dcecac069
Route
topical
Published
Effective Date 2022-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (100 mg) octisalate (50 mg) octocrylene
Inactive Ingredients
alcohol diisopropyl adipate butyloctyl salicylate isododecane silicon dioxide myristyl lactate hydroxypropyl cellulose, unspecified

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2022-10-25

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%


Medication Information

Warnings

For external use only

Flammable: do not use near heat, flame, or while smoking

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

• shake well before use • 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 this product from excessive heat and direct sun

Inactive Ingredients

alcohol denat. (36.8%), diisopropyl adipate, butyloctyl salicylate, isododecane, trimethylpentanediol/ adipic acid/glycerin crosspolymer, silica, myristyl lactate, hydroxypropylcellulose, fragrance

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

Questions?

1-877-978-6286

Do Not Use

on damaged or broken skin

Package Labeling:

Active Ingredients

Avobenzone 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 10%

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 swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Warnings

For external use only

Flammable: do not use near heat, flame, or while smoking

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

• shake well before use • 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 this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

alcohol denat. (36.8%), diisopropyl adipate, butyloctyl salicylate, isododecane, trimethylpentanediol/ adipic acid/glycerin crosspolymer, silica, myristyl lactate, hydroxypropylcellulose, fragrance

Questions?

1-877-978-6286

Do Not Use (Do not use)

on damaged or broken skin

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 10%

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 swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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