SPL v3
SPL
SPL Set ID e5e5777c-2f67-14ed-e053-2a95a90a58a5
Route
TOPICAL
Published
Effective Date 2022-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.7 g) Homosalate (9 g) Octisalate (4 g) Octocrylene (5 g)
Inactive Ingredients
Edetate Disodium Anhydrous Niacinamide Propylene Glycol Ceteth-10 Phosphate Dihexadecyl Phosphate Glycerin Ascorbyl Glucoside Phenoxyethanol Green Tea Leaf Cetostearyl Alcohol Diisopropyl Adipate Water Titanium Dioxide Mica Benzyl Alcohol Carbomer Homopolymer, Unspecified Type Chlorphenesin Alpha-tocopherol Acetate Xanthan Gum Coconut Oil Sodium Hydroxide Coco Glucoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-01

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

Purpose

Sunscreen Agent


Medication Information

Purpose

Sunscreen Agent

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

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 and surfaces

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 • 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 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

Inactive Ingredients

Water, Diisopropyl Adipate, Niacinamide, Cetearyl Alcohol, Phenoxyethanol, Carbomer, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Ascorbyl Glucoside, Glycerin, Chlorphenesin, Dicetyl Phosphate, Ceteth-10 Phosphate, Coco Glucoside,

Sodium Hydroxide, Propylene Glycol, Cocos Nucifera (Coconut) Oil, Xanthan Gum, Disodium EDTA, Camellia Sinensis Leaf Extract, Fragrance, Mica, Tocopheryl Acetate, Titanium Dioxide, Iron Oxides.

Principal Display Panel

BANANA

BOAT

NEW!

PROTECTION

+VITAMINS

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

VITAMINS

C+ B3

12 HOUR HYDRATION

NOURISH + PROTECT

FROM UV DAMAGE

Water Resistant

(80 Minutes)

4.5 FL. 0Z (133 mL)

When Using This Product

keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor

if rash occurs

​questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

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 Agent

Warnings

For external use only.

May stain some fabrics and surfaces

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 • 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 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

Inactive Ingredients

Water, Diisopropyl Adipate, Niacinamide, Cetearyl Alcohol, Phenoxyethanol, Carbomer, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Ascorbyl Glucoside, Glycerin, Chlorphenesin, Dicetyl Phosphate, Ceteth-10 Phosphate, Coco Glucoside,

Sodium Hydroxide, Propylene Glycol, Cocos Nucifera (Coconut) Oil, Xanthan Gum, Disodium EDTA, Camellia Sinensis Leaf Extract, Fragrance, Mica, Tocopheryl Acetate, Titanium Dioxide, Iron Oxides.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

BANANA

BOAT

NEW!

PROTECTION

+VITAMINS

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

VITAMINS

C+ B3

12 HOUR HYDRATION

NOURISH + PROTECT

FROM UV DAMAGE

Water Resistant

(80 Minutes)

4.5 FL. 0Z (133 mL)

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

​questions Or Comments? (​Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

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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