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

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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

Warnings

For external use only

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

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

Do Not Use

on damaged or broken skin

Questions?

1-877-978-6286

Other Information

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 10%

Inactive Ingredients

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

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

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

Warnings

For external use only

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

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

Do Not Use (Do not use)

on damaged or broken skin

Questions?

1-877-978-6286

Other Information (Other information)

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

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

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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