drug facts

drug facts
SPL v1
SPL
SPL Set ID 7da626f5-1ad7-4ea9-802d-302cf232ebf9
Route
topical
Published
Effective Date 2016-06-01
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 propylene glycol 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 2016-06-01
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 1-800-697-9868  Mon-Fri

Principle Display Panel

NDC: 41250-707-22

meijer

Sheer

Sunscreen

lotion

light, clean feel

dermatologist tested

30

Broad Spectrum

SPF 30

Water Resistant

(80 minutes)

3 FL. OZ.  (88 mL)



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 (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 (Active ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-800-697-9868  Mon-Fri

Principle Display Panel

NDC: 41250-707-22

meijer

Sheer

Sunscreen

lotion

light, clean feel

dermatologist tested

30

Broad Spectrum

SPF 30

Water Resistant

(80 minutes)

3 FL. OZ.  (88 mL)



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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:07.490285 · Updated: 2026-03-14T22:54:21.601813