f93b0091-6a41-ae6e-e053-6394a90a86d7

SPL v3
SPL
SPL Set ID f93b0091-6a41-ae6e-e053-6394a90a86d7
Route
topical
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (21.7 g)
Inactive Ingredients
levomenol beta vulgaris root fructooligosaccharides phenylethyl alcohol citrus bioflavonoids pentylene glycol titanium dioxide ferric oxide red ceramide ng medium-chain triglycerides mica polyglyceryl-2 dipolyhydroxystearate lactic acid sodium chloride fytic acid xanthan gum cyamopsis tetragonoloba whole tribehenin isostearic acid polyhydroxystearic acid (2300 mw) .alpha.-tocopherol acetate disteardimonium hectorite glycerin propanediol hyaluronate sodium palmitoyl hexapeptide-12 lecithin, soybean c13-15 alkane butyloctyl salicylate alkyl (c12-15) benzoate galactoarabinan allantoin water silicon dioxide polyglyceryl-3 pentaricinoleate polyglyceryl-3 diisostearate alpha-2-hs-glycoprotein

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-04-14

Purpose

Sunscreen

Description

Directions: Apply liberally 15 minutes before sun exposure. 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. 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 10am - 2pm, wear long-sleeved shirts, pants, hats, and sunglasses. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.


Medication Information

Warnings

Warnings:

For external use only.

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

Stop use and ask a doctor is rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use on damaged or broken skin.

Active Ingredient

Purpose

Sunscreen

Description

Directions: Apply liberally 15 minutes before sun exposure. 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. 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 10am - 2pm, wear long-sleeved shirts, pants, hats, and sunglasses. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

Use

Use:

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

Directions:

Apply liberally 15 minutes before sun exposure.

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.

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 10am - 2pm, wear long-sleeved shirts, pants, hats, and sunglasses.

Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

Section 51727-6

Section 51945-4

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

Warnings:

For external use only.

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

Stop use and ask a doctor is rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use on damaged or broken skin.

Active Ingredient (55106-9)

Purpose

Sunscreen

Use

Use:

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

Directions:

Apply liberally 15 minutes before sun exposure.

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.

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 10am - 2pm, wear long-sleeved shirts, pants, hats, and sunglasses.

Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)