2e0a0cd6-c302-2017-e063-6394a90a60b8

SPL v4
SPL
SPL Set ID 2e0a0cd6-c302-2017-e063-6394a90a60b8
Route
topical
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (7.5 g)
Inactive Ingredients
tridecane octyldodecanol ethylhexyl olivate phenethyl alcohol calcium sodium borosilicate ferric oxide red sodium gluconate maltodextrin pentylene glycol titanium dioxide medium-chain triglycerides mica polyglyceryl-2 dipolyhydroxystearate glycerin propanediol hyaluronate sodium lecithin, soybean galactoarabinan water cetyl alcohol panthenol caffeine artemisia capillaris flower polyglyceryl-3 diisostearate niacinamide tocopherol arnica montana flower glycine soja (soybean) oil undecane glyceryl oleate palmitoyl tripeptide-5 squalane polyhydroxystearic acid (2300 mw)

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, and 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 if 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.

Purpose

Sunscreen

Directions

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

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

Use

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.

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 if 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.

Purpose

Sunscreen

Directions

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

Use

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.

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

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