Moisturizer Sunscreen Spf 50

Moisturizer Sunscreen Spf 50
SPL v2
SPL
SPL Set ID 1f47e508-58dd-fab4-e063-6394a90a668a
Route
TOPICAL
Published
Effective Date 2024-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (1 g) Oxybenzone (0.6 g) Avobenzone (1.6 g) Octisalate (2 g)
Inactive Ingredients
Carbomer 940 Water Glycerin C12-15 Alkyl Ethylhexanoate Cetyl Alcohol Silicon Dioxide Butylene Glycol Cyclomethicone Sucrose Polystearate Glyceryl Stearate Se Peg-100 Stearate Cetearyl Glucoside Cetostearyl Alcohol Cetyl Palmitate Edetate Disodium Ascorbyl Tocopheryl Maleate Panthenol Polysorbate 20 Camellia Oleifera Seed Butylated Hydroxytoluene Phenoxyethanol Ethylhexylglycerin Retinol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-09

Description

Benzophenone-3 4% Butyl Methoxydibenzoylmethane 1.5% Ethylhexyl Salicylate 5.0% Octocrylene 2.5%

Purpose

Sunscreen


Medication Information

Indications and Usage

Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours.

Purpose

Sunscreen

Description

Benzophenone-3 4% Butyl Methoxydibenzoylmethane 1.5% Ethylhexyl Salicylate 5.0% Octocrylene 2.5%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Warnings

Warnings

Do not use on damaged or broken skin

When using this product

  • keep out of the eye area
  • rinse with water to remove
  • stop use and ask a doctor if rash or irritation develops
  • for external use onlyl
  • keep out of reach of children
Directions

Directions: for sunscreen use

• apply generously 15 minutes before sun exposure

• apply to all skin exposed to the sun

• children under 6 months of age: ask a doctor

Active Ingredients

Benzophenone-3 4%

Butyl Methoxydibenzoylmethane 1.5%

Ethylhexyl Salicylate 5.0%

Octocrylene 2.5%

Inactive Ingredients

Inactive Ingredients: Aqua, Glycerin, C12-15 Alkyl Benzoate, Cetyl Alcohol, Silica, Butylene Glycol, Cyclopentasiloxane, Sucrose Polystearate, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Glucoside, Cetearyl Alcohol, Carbomer, Cetyl Palmitate, Disodium EDTA, Tocopheryl Acetate (Vitamin E), Sodium Hydroxide, Panthenol, Retinol, Polysorbate 20, Camellia Oleifera Seed Extract, BHT, Phenoxyethanol, Ethylhexylglycerin

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Structured Label Content

Indications and Usage (34067-9)

Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Purpose

Sunscreen

Warnings

Warnings

Do not use on damaged or broken skin

When using this product

  • keep out of the eye area
  • rinse with water to remove
  • stop use and ask a doctor if rash or irritation develops
  • for external use onlyl
  • keep out of reach of children
Directions

Directions: for sunscreen use

• apply generously 15 minutes before sun exposure

• apply to all skin exposed to the sun

• children under 6 months of age: ask a doctor

Active Ingredients

Benzophenone-3 4%

Butyl Methoxydibenzoylmethane 1.5%

Ethylhexyl Salicylate 5.0%

Octocrylene 2.5%

Inactive Ingredients

Inactive Ingredients: Aqua, Glycerin, C12-15 Alkyl Benzoate, Cetyl Alcohol, Silica, Butylene Glycol, Cyclopentasiloxane, Sucrose Polystearate, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Glucoside, Cetearyl Alcohol, Carbomer, Cetyl Palmitate, Disodium EDTA, Tocopheryl Acetate (Vitamin E), Sodium Hydroxide, Panthenol, Retinol, Polysorbate 20, Camellia Oleifera Seed Extract, BHT, Phenoxyethanol, Ethylhexylglycerin

Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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