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
Description

AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%

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 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
Do Not Use

on damaged or broken skin

Other Information


  • protect this product from excessive heat and direct sun

Active Ingredients

AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%

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)













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 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
Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)


  • protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%

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)













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