drug facts

drug facts
SPL v1
SPL
SPL Set ID af884151-12a8-408b-9b35-5959201a8fb2
Route
topical
Published
Effective Date 2015-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (10 g) octocrylene (6 g)
Inactive Ingredients
water cetostearyl alcohol stearyl alcohol glycerin phenoxyethanol caprylic alcohol cetyl alcohol carboxypolymethylene ceteth-10 phosphate dihexadecyl phosphate coco glucoside methylparaben xanthan gum propylparaben sodium hydroxide edetate disodium hydrogenated methyl abietate sodium ascorbyl phosphate .alpha.-tocopherol acetate aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-12-28
Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%

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. - 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 month of age: Ask a doctor

Other Information
  • protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Cetearyl Alcohol, Stearyl Alcohol, Glycerin, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Cetyl Alcohol, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Methylparaben, Xanthan Gum, Propylparaben, Sodium Hydroxide, Disodium EDTA, Hydrogenated Methyl Abietate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Copolymer, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.



Description

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%

Principal Display Panel


NDC 55301-206-19

exchange select

FAMILY VALUE

SPORT

SUNSCREEN LOTION

50+

BROAD SPECTRUM

SPF 50+

UVA/UVB Protection

Water Resistant

(80 Minutes)

16 FL.OZ.

(473 mL)







Do Not Use

on damaged or broken skin



Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%



Questions Or Comments?

Call 1-386-673-2024



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. - 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 month of age: Ask a doctor

Other Information (Other information)
  • protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Cetearyl Alcohol, Stearyl Alcohol, Glycerin, Phenoxyethanol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Cetyl Alcohol, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Methylparaben, Xanthan Gum, Propylparaben, Sodium Hydroxide, Disodium EDTA, Hydrogenated Methyl Abietate, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Copolymer, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.



Principal Display Panel


NDC 55301-206-19

exchange select

FAMILY VALUE

SPORT

SUNSCREEN LOTION

50+

BROAD SPECTRUM

SPF 50+

UVA/UVB Protection

Water Resistant

(80 Minutes)

16 FL.OZ.

(473 mL)







Do Not Use (Do not use)

on damaged or broken skin



Active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 10.0%, Octocrylene 6.0%



Questions Or Comments? (Questions or comments?)

Call 1-386-673-2024



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: 2026-02-15T11:56:05.091093 · Updated: 2026-03-14T22:54:17.721451