Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4e600038-f9f0-49df-8f74-ca8a3e3d7d7e
Route
TOPICAL
Published
Effective Date 2015-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2 g) Padimate O (1.4 g)
Inactive Ingredients
Mineral Oil Coconut Oil Cocoa Butter Aloe Vera Leaf Banana Vitamin A Palmitate .alpha.-tocopherol Acetate Carrot Phenoxyethanol Methylparaben Isopropylparaben Isobutylparaben Butylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-08-03

Description

Octinoxate 2.0%, Padimate O 1.4%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen



Description

Octinoxate 2.0%, Padimate O 1.4%

Uses
  • helps prevent sunburn
Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.



For external use only

Directions


  • apply liberally 15 minutes before sun exposure
  • reapply after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every2 hours
  • children under 6 months of age: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information


  • protect this product from excessive heat and direct sun

Active Ingredients

Octinoxate 2.0%, Padimate O 1.4%



Inactive Ingredients

Mineral Oil, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Aloe Barbadensis Leaf Extract, Musa Sapientum (Banana) Fruit Extract, Retinyl Palmitate (and) Zea Mays (Corn) Oil (and) BHA (and) BHT, Tocopheryl Acetate, Daucus Carota Sativa (Carrot) Root Extract, Fragrance: Alpine Aromatics Coco Rum Banana #122-778, Phenoxyethanol (and) Methylparaben (and) Isopropylparaben (and) Isobutylparaben (and) Butylparaben.

Principal Display Panel





62296-7031-6



DEEP TANNING



DARK TANNING



SPF 4



ALOE VERA

EXOTIC MOISTURIZERS

TROPICAL OIL

ULTA

8 fl oz/ 236 ml













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 Childrem

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

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.



For external use only

Directions


  • apply liberally 15 minutes before sun exposure
  • reapply after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every2 hours
  • children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)


  • protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Octinoxate 2.0%, Padimate O 1.4%



Inactive Ingredients (Inactive ingredients)

Mineral Oil, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Aloe Barbadensis Leaf Extract, Musa Sapientum (Banana) Fruit Extract, Retinyl Palmitate (and) Zea Mays (Corn) Oil (and) BHA (and) BHT, Tocopheryl Acetate, Daucus Carota Sativa (Carrot) Root Extract, Fragrance: Alpine Aromatics Coco Rum Banana #122-778, Phenoxyethanol (and) Methylparaben (and) Isopropylparaben (and) Isobutylparaben (and) Butylparaben.

Principal Display Panel (Principal Display panel)





62296-7031-6



DEEP TANNING



DARK TANNING



SPF 4



ALOE VERA

EXOTIC MOISTURIZERS

TROPICAL OIL

ULTA

8 fl oz/ 236 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

Keep Out of Reach of Childrem (Keep out of reach of childrem)

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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