drug facts

drug facts
SPL v1
SPL
SPL Set ID 20144a32-26c6-47ea-8958-7407f3d0b228
Route
topical
Published
Effective Date 2013-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (10 g) octisalate (5 g) octocrylene
Inactive Ingredients
water ethylhexyl palmitate sorbitol diethylhexyl syringylidenemalonate trolamine glyceryl monostearate edetate disodium peg-100 stearate tricaprylin oleth-3 tocopherol sodium ascorbyl phosphate aloe vera leaf benzyl alcohol chlorphenesin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-07-16

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate    5.0% Octocrylene 10.0%


Medication Information

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures ( see Directions) decrease the risk of skin cancer and early skin aging caused by sun.
Purpose

Sunscreen



Directions
  •     apply literally 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 increase your risk of skin cancer and early skin

aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF  of 15 or higher and other sun protection measures including:





  •     Limit time in the sun, especially from 10 am - 2 pm
  •     Wear long sleeves shirts, pants, hats and sunglasses
  •     children under 6 month of age: Ask a doctor
Other Information

protect this product from excessive heat and direct sun



Inactive Ingredients

water, Ethylhexyl Plamitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Diethylhexyl Syringylidenemalonate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG_100 Stearate, Caprylic/Capric Triglyceride,Disodium EDTA, Oleth-3, Tocopherol,Aloe Barbadensis Leaf juice Powder, Sodium Acorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.



Description

Avobenzone 3.0% Homosalate 10.0% Octisalate    5.0% Octocrylene 10.0%

Principal Display Panel

publix

SUNSCREEN

LOTION

BROAD SPECTRUM

SPF 30

MOISTURIZING

WATER RESISTlNT

(80 MINTUES)

UVA/UVB Protection

8 FL OZ (236 mL)



publix

SUNSCREEN

LOTION

BROAD SPECTRUM

SPF 30

MOISTURIZING

WATER RESISTlNT

(80 MINTUES)

UVA/UVB Protection

3 FL OZ (88 mL)

Section 50565-1

Keep out of the reach of children.

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

May stain some fabrics

Active Ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate    5.0%

Octocrylene 10.0%





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

Stop Use and Ask A Doctor If

rash occurs




Structured Label Content

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures ( see Directions) decrease the risk of skin cancer and early skin aging caused by sun.
Purpose

Sunscreen



Directions
  •     apply literally 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 increase your risk of skin cancer and early skin

aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF  of 15 or higher and other sun protection measures including:





  •     Limit time in the sun, especially from 10 am - 2 pm
  •     Wear long sleeves shirts, pants, hats and sunglasses
  •     children under 6 month of age: Ask a doctor
Other Information (Other information)

protect this product from excessive heat and direct sun



Inactive Ingredients (Inactive ingredients)

water, Ethylhexyl Plamitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Diethylhexyl Syringylidenemalonate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG_100 Stearate, Caprylic/Capric Triglyceride,Disodium EDTA, Oleth-3, Tocopherol,Aloe Barbadensis Leaf juice Powder, Sodium Acorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.



Principal Display Panel

publix

SUNSCREEN

LOTION

BROAD SPECTRUM

SPF 30

MOISTURIZING

WATER RESISTlNT

(80 MINTUES)

UVA/UVB Protection

8 FL OZ (236 mL)



publix

SUNSCREEN

LOTION

BROAD SPECTRUM

SPF 30

MOISTURIZING

WATER RESISTlNT

(80 MINTUES)

UVA/UVB Protection

3 FL OZ (88 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.

May stain some fabrics

Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 10.0%

Octisalate    5.0%

Octocrylene 10.0%





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 occurs




Advanced Ingredient Data


Raw Label Data

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