e53509bf-6bb7-2db7-e053-2a95a90aae18

SPL v2
SPL
SPL Set ID e53509bf-6bb7-2db7-e053-2a95a90aae18
Route
topical
Published
Effective Date 2022-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (4.5 g) avobenzone (2 g) homosalate (5.5 g) octocrylene (4 g)
Inactive Ingredients
diisopropyl adipate niacinamide ascorbyl glucoside glycerin water benzyl alcohol dihexadecyl phosphate coco glucoside sodium hydroxide propylene glycol coconut oil xanthan gum edetate disodium anhydrous chlorphenesin mica .alpha.-tocopherol acetate phenoxyethanol ceteth-10 phosphate green tea leaf titanium dioxide cetostearyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-10-01 Until 2026-12-01

Purpose

Sunscreen Agent

Description

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%


Medication Information

Warnings

For external use only

• May stain some fabrics and surfaces.

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

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. Spendi ng 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

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Diisopropyl Adipate, Niacinamide, Cetearyl Alcohol, Phenoxyethanol, Carbomer, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Glycerin, Ascorbyl Glucoside, Chlorphenesin, Dicetyl Phosphate, Ceteth10 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

Description

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Section 51945-4

BANANA

BOAT

NEW!

Protection

+ Vitamins

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 30

30

VITAMINS

C + B 3

12 HOUR HYDRATION

NOURISH + PROTECT

FROM UV DAMAGE

Water Resistant

(80 Minutes)

4.5 FL OZ. (!33mL)

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

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

Warnings

For external use only

• May stain some fabrics and surfaces.

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

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. Spendi ng 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

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Diisopropyl Adipate, Niacinamide, Cetearyl Alcohol, Phenoxyethanol, Carbomer, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Glycerin, Ascorbyl Glucoside, Chlorphenesin, Dicetyl Phosphate, Ceteth10 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

Section 51945-4 (51945-4)

BANANA

BOAT

NEW!

Protection

+ Vitamins

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 30

30

VITAMINS

C + B 3

12 HOUR HYDRATION

NOURISH + PROTECT

FROM UV DAMAGE

Water Resistant

(80 Minutes)

4.5 FL OZ. (!33mL)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients

Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

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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