SPL v3
SPL
SPL Set ID e64de59e-b8db-522e-e053-2a95a90ac458
Route
TOPICAL
Published
Effective Date 2022-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (5 g) Octisalate (4 g) Avobenzone (2.7 g) Homosalate (9 g)
Inactive Ingredients
Phenoxyethanol Xanthan Gum Coco Glucoside Diisopropyl Adipate Mica Ascorbyl Glucoside Ferric Oxide Yellow Titanium Dioxide Sodium Hydroxide Green Tea Leaf Niacinamide Propylene Glycol Coconut Oil .alpha.-tocopherol Acetate Dihexadecyl Phosphate Water Cetostearyl Alcohol Benzyl Alcohol Glycerin Ceteth-10 Phosphate Edetic Acid Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-10-01 Until 2027-10-01

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

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, Glycerin, Ascorbyl Glucoside, Chlorphenesin, Dicetyl Phosphate, Ceteth 10 Phosphate, Coco Glucoside,

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

Stop and Ask A Doctor

if rash occurs.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

When Sing This Product

keep out of eyes. Rinse with water to remove.

Principal Display Panel

BANANA

BOAT

NEW!

Protection

+ Vitamins

face

SUNSCREEN LOTION

UVA/ UVB BROAD SPECTRUM SPF 50+

50+

VITAMINS

C + B3

12 HOUR HYDRATION

NOURISH + PROTECT

FROM UV DAMAGE

Water Resistant

(80 Minutes)

2.0 FL. OZ. (59mL)

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 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, Glycerin, Ascorbyl Glucoside, Chlorphenesin, Dicetyl Phosphate, Ceteth 10 Phosphate, Coco Glucoside,

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

Stop and Ask A Doctor (Stop and ask a doctor)

if rash occurs.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

When Sing This Product (When sing this product)

keep out of eyes. Rinse with water to remove.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

BANANA

BOAT

NEW!

Protection

+ Vitamins

face

SUNSCREEN LOTION

UVA/ UVB BROAD SPECTRUM SPF 50+

50+

VITAMINS

C + B3

12 HOUR HYDRATION

NOURISH + PROTECT

FROM UV DAMAGE

Water Resistant

(80 Minutes)

2.0 FL. OZ. (59mL)

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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