drug facts

drug facts
SPL v1
SPL
SPL Set ID 6620fa42-eb29-4cec-ae2e-c30e91fa752a
Route
topical
Published
Effective Date 2016-05-25
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 caprylyl glycol 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 2016-05-25
Purpose

Sunscreen

Description

AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%

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 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 months 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%, HOMOSALATE 10%, OCTOCRYLENE 6%

Principal Display Panel


NDC 11822-9024-9

VALUE SIZE

RITE AID

RENEWAL

sunscreen

LOTION

BROAD SPECTRUM

SPF 50+

UVA/UVB Protection

Water Resistant (80 Minutes)

Vitamin E and Aloe

50+

16 FL OZ

(473 mL)













Do Not Use

on damaged or broken skin

Active Ingredients

AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%

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 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 months 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 11822-9024-9

VALUE SIZE

RITE AID

RENEWAL

sunscreen

LOTION

BROAD SPECTRUM

SPF 50+

UVA/UVB Protection

Water Resistant (80 Minutes)

Vitamin E and Aloe

50+

16 FL OZ

(473 mL)













Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%

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: 2026-02-15T11:56:07.456982 · Updated: 2026-03-14T22:54:21.601813