drug facts

drug facts
SPL v1
SPL
SPL Set ID 7c1e0998-74b8-45fe-a03a-17c431322d47
Route
topical
Published
Effective Date 2012-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (15 g) octisalate (5 g) octocrylene (10 g) oxybenzone (6 g)
Inactive Ingredients
water glyceryl monostearate docosanol palmitic acid stearic acid lauryl alcohol myristyl alcohol cetyl alcohol cellulose, microcrystalline carboxymethylcellulose sodium peg-100 stearate butylene glycol diethylhexyl syringylidenemalonate tricaprin benzyl alcohol chlorphenesin tocopherol vitamin a palmitate sodium ascorbyl phosphate edetate disodium

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2012-11-21

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 15.0% Octisalate    5.0% Octocrylene 10.0% Oxybenzone 6.0%


Medication Information

Warnings
For external use only
Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in water

Purpose
Sunscreen

Directions
  • shake well
  • apply generously and evenly before sun exposure and as needed
  • children under 6 months of age: ask a doctor
  • reapply frequently and after towel drying, swimming or perspiring

Other Information
  • may stain some materials

Inactive Ingredients
Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.

Description

Avobenzone 3.0% Homosalate 15.0% Octisalate    5.0% Octocrylene 10.0% Oxybenzone 6.0%

Principal Display Panel
select brand

the lower price name brand

SUNSCREEN LOTION

70 SPF

UVA/UVB

Photostable

MOISTURIZING

Broad Spectrum

Protection

VERY WATER RESISTANT

8 FL OZ(237 mL)







Section 50565-1
Keep out of the reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Active Ingredients
Avobenzone 3.0%

Homosalate 15.0%

Octisalate    5.0%

Octocrylene 10.0%

Oxybenzone 6.0%

When Using This Product
  • keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts.


Structured Label Content

Warnings
For external use only
Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in water

Purpose
Sunscreen

Directions
  • shake well
  • apply generously and evenly before sun exposure and as needed
  • children under 6 months of age: ask a doctor
  • reapply frequently and after towel drying, swimming or perspiring

Other Information (Other information)
  • may stain some materials

Inactive Ingredients (Inactive ingredients)
Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.

Principal Display Panel
select brand

the lower price name brand

SUNSCREEN LOTION

70 SPF

UVA/UVB

Photostable

MOISTURIZING

Broad Spectrum

Protection

VERY WATER RESISTANT

8 FL OZ(237 mL)







Section 50565-1 (50565-1)
Keep out of the reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Active Ingredients (Active ingredients)
Avobenzone 3.0%

Homosalate 15.0%

Octisalate    5.0%

Octocrylene 10.0%

Oxybenzone 6.0%

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash or irritation develops and lasts.


Advanced Ingredient Data


Raw Label Data

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