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
Purpose

Sunscreen

Description

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

Medication Information

Warnings

For external use only

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

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

Other Information

•    protect this product from excessive heat and direct sun

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.

Description

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

Do Not Use

on damaged or broken skin

Active Ingredients

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

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

Warnings

For external use only

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

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

Other Information

•    protect this product from excessive heat and direct sun

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.

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients

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

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