Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID bc273e5f-76f4-4630-90bf-ae7f1213128e
Route
TOPICAL
Published
Effective Date 2016-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (8 g) Octisalate (5 g) Octocrylene (4 g) Oxybenzone
Inactive Ingredients
Water Caprylyl Trisiloxane Glyceryl Monostearate Peg-100 Stearate Cetyl Alcohol Silicon Dioxide Benzyl Alcohol Caprylyl Glycol Diethylhexyl 2,6-naphthalate Phenoxyethanol Chlorphenesin Dimethicone Xanthan Gum Docosanol Ethylhexyl Stearate Trideceth-6 Edetate Disodium Ethylhexylglycerin Butylated Hydroxytoluene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-03-08
Description

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 4.0%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 4.0%

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

Directions

•    apply liberally 15 minutes before sun exposure

•    reapply:

•    after 80 minutes of swimming or sweating

•    immediately after towel drying

•    at least every 2 hours 

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 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-sleeved shirts, pants, hats, and sunglasses

•    children under 6 months: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

•    protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 4.0%

Inactive Ingredients

Water, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Propylene Glycol, Silica, Benzyl Alcohol, Caprylyl Glycol, Diethylhexyl 2,6-Naphthalate, Phenoxyethanol, Sodium Polyacrylate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Chlorphenesin, Cetyl Dimethicone, Dimethicone, Xanthan Gum, Fragrance, Behenyl Alcohol, Ethylhexyl Stearate, Trideceth-6, Disodium EDTA, Ethylhexylglycerin, BHT.

Questions Or Comments?

Call 1-800-632-6900

Principle Display Label

NDC: 30142-690-13

COMPARE TO

NEUTROGENA ULTRA SHEER

* see back panel

Kroger

SHEER

dry-touch sunscreen

30

Broad Spectrum SPF 30

  • Water Resistant (80 minutes)
  • Light Feel
  • Dermatologist Tested
  • Oil Free
  • Won't Clog Pores
  • UVA/UVB Protection

4 FL OZ (118mL)

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 product is swallowed, get medical help or contact a Poison Control Center right away.

•    May stain some fabrics

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

Directions

•    apply liberally 15 minutes before sun exposure

•    reapply:

•    after 80 minutes of swimming or sweating

•    immediately after towel drying

•    at least every 2 hours 

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 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-sleeved shirts, pants, hats, and sunglasses

•    children under 6 months: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information

•    protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 4.0%

Inactive Ingredients

Water, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Propylene Glycol, Silica, Benzyl Alcohol, Caprylyl Glycol, Diethylhexyl 2,6-Naphthalate, Phenoxyethanol, Sodium Polyacrylate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Chlorphenesin, Cetyl Dimethicone, Dimethicone, Xanthan Gum, Fragrance, Behenyl Alcohol, Ethylhexyl Stearate, Trideceth-6, Disodium EDTA, Ethylhexylglycerin, BHT.

Questions Or Comments? (Questions or comments?)

Call 1-800-632-6900

Principle Display Label

NDC: 30142-690-13

COMPARE TO

NEUTROGENA ULTRA SHEER

* see back panel

Kroger

SHEER

dry-touch sunscreen

30

Broad Spectrum SPF 30

  • Water Resistant (80 minutes)
  • Light Feel
  • Dermatologist Tested
  • Oil Free
  • Won't Clog Pores
  • UVA/UVB Protection

4 FL OZ (118mL)

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

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

If product is swallowed, get medical help or contact a Poison Control Center right away.

•    May stain some fabrics

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:06.296958 · Updated: 2026-03-14T22:54:18.927073