Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID cb9d12eb-6645-43f4-9f81-31af13c5c68d
Route
TOPICAL
Published
Effective Date 2016-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.9 g) Octocrylene (2 g) Oxybenzone (1.5 g)
Inactive Ingredients
Water Diisopropyl Adipate Mineral Oil Propylene Glycol Petrolatum Caprylyl Glycol Cetyl Alcohol Glyceryl Monostearate Peg-100 Stearate Trolamine Cocoa Butter Shea Butter Coconut Oil Soybean Oil Sunflower Oil Edetate Disodium Green Tea Leaf Sodium Ascorbyl Phosphate .alpha.-tocopherol Acetate Aloe Vera Leaf Banana Phenoxyethanol Methylparaben Benzyl Alcohol Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-02-16

Description

AVOBENZONE 0.9%, OCTOCRYLENE 2.0%, OXYBENZONE 1.5%

Purpose

Sunscreen


Medication Information

Purpose


Sunscreen



Description

AVOBENZONE 0.9%, OCTOCRYLENE 2.0%, OXYBENZONE 1.5%

Uses

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to prevent sunburn, not skin cancer or early aging.

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
  • 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 0.9%, OCTOCRYLENE 2.0%, OXYBENZONE 1.5%

Inactive Ingredients

Water, Diisopropyl Adipate, Mineral Oil, Propylene Glycol, Petrolatum, Polyglyceryl-3 Methylglucose Distearate, Caprylyl Glycol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, VP/Eicosene Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea), Butter, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Disodium EDTA, Camellia Sinensis Leaf Extract, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice Powder, Panthenol, Daucus Carota Sativa (Carrot) Root Extract, Musa Sapientum (Banana) Fruit Extract, Phenoxyethanol, Methylparaben, Benzyl Alcohol, Propylparaben, Fragrance.

Principal Display Panel

NDC 41250-360-57

meijer

Sunscreen lotion

hypoallergenic

moisturizing

8

SPF 8

Water Resistant

(80 minutes)

10 Fl. Oz. (295 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

Purpose


Sunscreen



Warnings

Skin Cancer/Skin Aging Alert:  Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to prevent sunburn, not skin cancer or early aging.

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
  • 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

AVOBENZONE 0.9%, OCTOCRYLENE 2.0%, OXYBENZONE 1.5%

Inactive Ingredients (Inactive ingredients)

Water, Diisopropyl Adipate, Mineral Oil, Propylene Glycol, Petrolatum, Polyglyceryl-3 Methylglucose Distearate, Caprylyl Glycol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, VP/Eicosene Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea), Butter, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Disodium EDTA, Camellia Sinensis Leaf Extract, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice Powder, Panthenol, Daucus Carota Sativa (Carrot) Root Extract, Musa Sapientum (Banana) Fruit Extract, Phenoxyethanol, Methylparaben, Benzyl Alcohol, Propylparaben, Fragrance.

Principal Display Panel

NDC 41250-360-57

meijer

Sunscreen lotion

hypoallergenic

moisturizing

8

SPF 8

Water Resistant

(80 minutes)

10 Fl. Oz. (295 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

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