Spf30 Sunscreen Lotion And Spf15 Lip Balm

Spf30 Sunscreen Lotion And Spf15 Lip Balm
SPL v2
SPL
SPL Set ID 6c40259b-565a-46d0-90d0-ccc186764552
Route
TOPICAL
Published
Effective Date 2018-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octocrylene (50 mg) Octisalate (20 mg)
Inactive Ingredients
Cetostearyl Alcohol Dimethicone Caprylyl Glycol Phenoxyethanol Glyceryl Monostearate Vinylpyrrolidone/hexadecene Copolymer Levomenol Carboxypolymethylene Trolamine Edetate Disodium Anhydrous Coconut Water Glycerin Medium-chain Triglycerides Potassium Cetyl Phosphate Mineral Oil Ceresin Coconut Oil Ethylhexyl Palmitate High Density Polyethylene Tridecyl Trimellitate Shea Butter Butylated Hydroxytoluene .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-01
Description

Avobenzone 3%, Homosalate 10%, Octocrylene10%, Octisalate 5%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10%, Octocrylene10%, Octisalate 5%

Uses

•Helps prevent sunburn

Warnings

Spending time in the sun increases your risk of skin cnacer or early skin aging. this product has been shown only to prevent sunburn skin cancer or early skin aging. this product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert: NOT NOT

For external use only.

Warnings

For external use only.

Warnings:

Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown only to prevent sunburn skin cancer or early skin aging. This product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert: NOT NOT

For external use only.

Directions

Non-Water Resistant Product • Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months: Ask a doctor







Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. to 2 p.m. • Wear long sleeve shirts, pants, hats and sunglasses. Sun Protection Measures.



Do Not Use

on damaged or broken skin.

Questions?

Call AP Specialties

Other Information
  • Protect from excessive heat and direct sun.
Other Information

• Protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octocrylene10%, Octisalate 5%

Inactive Ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Inactive Ingredients.

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs.

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.

Structured Label Content

Uses

•Helps prevent sunburn

Purpose

Sunscreen

Warnings (WARNINGS)

Spending time in the sun increases your risk of skin cnacer or early skin aging. this product has been shown only to prevent sunburn skin cancer or early skin aging. this product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert: NOT NOT

For external use only.

Warnings

For external use only.

Warnings: (WARNINGS:)

Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown only to prevent sunburn skin cancer or early skin aging. This product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert: NOT NOT

For external use only.

Directions

Non-Water Resistant Product • Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months: Ask a doctor







Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. to 2 p.m. • Wear long sleeve shirts, pants, hats and sunglasses. Sun Protection Measures.



Do Not Use (Do not use)

on damaged or broken skin.

Questions?

Call AP Specialties

Other Information
  • Protect from excessive heat and direct sun.
Other Information (Other information)

• Protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octocrylene10%, Octisalate 5%

Inactive Ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Inactive Ingredients. (Inactive ingredients.)

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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

if rash occurs.

Stop Use and Ask A Doctor  (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 right away.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:16.656312 · Updated: 2026-03-14T23:01:42.949822