SPL v5
SPL
SPL Set ID 353353b9-54f8-4300-9632-7615de394076
Route
TOPICAL
Published
Effective Date 2012-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (8 g) Oxybenzone (3.5 g) Avobenzone (2.5 g)
Inactive Ingredients
High Density Polyethylene Propylparaben Octyldodecanol Silicon Dioxide Sodium Chloride Sodium Propoxyhydroxypropyl Thiosulfate Silica Butyloctyl Salicylate Ethylhexyl Palmitate Hydrated Silica Cyclomethicone 5 Cyclomethicone 6 Benzyl Alcohol Methylparaben Vitamin A Palmitate Ascorbic Acid Water Microcrystalline Wax Caprylyl Glycol Edetate Disodium Peg-8 Dimethicone Aloe Vera Leaf .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-11-19 Until 2027-07-01

Description

Avobenzone 2.5%, Octocrylene 8.0%, Oxybenzone 3.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.5%, Octocrylene 8.0%, Oxybenzone 3.5%

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

May stain some fabrics.

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: Ask a doctor 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 a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses.

Do Not Use

on damaged or broken skin

Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients

Avobenzone 2.5%, Octocrylene 8.0%, Oxybenzone 3.5%

Inactive Ingredients

Water, Hydrogenated Polyisobutene, Lauryl PEG-8 Dimethicone, Butyloctyl Salicylate,Ethylhexyl Palmitate, Hydrated Silica, Cyclopentasiloxane, Cyclohexasiloxane, Sodium Chloride, Benzyl Alcohol, Beeswax, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Methylparaben, Microcrystalline Wax, Polyethylene, Caprylyl Glycol, Propylparaben,Disodium EDTA, Stearoxy Dimethicone, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice Powder, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT(R)

KIDS

MAX PROTECT & PLAY(TM)

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 100

100

PROTECTS FROM 99%

OF BURNING RAYS

PEDIATRICIAN TESTED

High Endurance vs. Water

Water Resistant

(80 Minutes)

4 FL.OZ. (118 mL)

When Using This Product

Keep out of eyse. 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.


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

May stain some fabrics.

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: Ask a doctor 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 a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses.

Do Not Use (Do not use)

on damaged or broken skin

Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients (Active ingredients)

Avobenzone 2.5%, Octocrylene 8.0%, Oxybenzone 3.5%

Inactive Ingredients

Water, Hydrogenated Polyisobutene, Lauryl PEG-8 Dimethicone, Butyloctyl Salicylate,Ethylhexyl Palmitate, Hydrated Silica, Cyclopentasiloxane, Cyclohexasiloxane, Sodium Chloride, Benzyl Alcohol, Beeswax, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Methylparaben, Microcrystalline Wax, Polyethylene, Caprylyl Glycol, Propylparaben,Disodium EDTA, Stearoxy Dimethicone, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice Powder, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT(R)

KIDS

MAX PROTECT & PLAY(TM)

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 100

100

PROTECTS FROM 99%

OF BURNING RAYS

PEDIATRICIAN TESTED

High Endurance vs. Water

Water Resistant

(80 Minutes)

4 FL.OZ. (118 mL)

When Using This Product (When using this product)

Keep out of eyse. 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.


Advanced Ingredient Data


Raw Label Data

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