SPL v4
SPL
SPL Set ID c7b71be3-f906-bd09-e053-2995a90adc61
Route
TOPICAL
Published
Effective Date 2021-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (10 g) Octisalate (5 g) Avobenzone (3 g)
Inactive Ingredients
Medium-chain Triglycerides Petrolatum Ceresin Ethylhexyl Palmitate Vinylpyrrolidone/eicosene Copolymer Saccharin Sodium Anhydrous Butyloctyl Salicylate Polyethylene Glycol 400 Rice Bran .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-01

Description

Avobenzone 3.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Octisalate 5.0%, Octocrylene 10.0%

Uses

• helps prevent sunburn.

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 • reapply after eating or drinking • 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. •Children under 6 months: 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 3.0%, Octisalate 5.0%, Octocrylene 10.0%

Inactive Ingredient

Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, VP/Eicosene Copolymer, Butyloctyl Salicylate, Flavor, PEG-8, Oryza Sativa (Rice) Bran Wax, Sodium Saccharin, Tocopheryl Acetate.

Questions / Comments

1-800-NO UV RAY

Principal Display Panel

TROPICAL FLAVOR

HAWAIIAN TROPIC(R)

SUNSCREEN STICK

LIP BALM

12 HR MOISTURIZATION

WATER RESISTANT (80 minutes)

30

DERM TESTED | VEGAN

BROAD SPECTRUM SPF30 UVA/UVB



0.14 OZ (4.25g)

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.


Structured Label Content

Uses

• helps prevent sunburn.

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 • reapply after eating or drinking • 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. •Children under 6 months: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin.

Other Information

• protect this product from excessive heat and direct sun.

Active Ingredients

Avobenzone 3.0%, Octisalate 5.0%, Octocrylene 10.0%

Inactive Ingredient (Inactive ingredient)

Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, VP/Eicosene Copolymer, Butyloctyl Salicylate, Flavor, PEG-8, Oryza Sativa (Rice) Bran Wax, Sodium Saccharin, Tocopheryl Acetate.

Questions / Comments

1-800-NO UV RAY

Principal Display Panel

TROPICAL FLAVOR

HAWAIIAN TROPIC(R)

SUNSCREEN STICK

LIP BALM

12 HR MOISTURIZATION

WATER RESISTANT (80 minutes)

30

DERM TESTED | VEGAN

BROAD SPECTRUM SPF30 UVA/UVB



0.14 OZ (4.25g)

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.


Advanced Ingredient Data


Raw Label Data

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