Spf 30 Stay Put Sunscreen Lotion

Spf 30 Stay Put Sunscreen Lotion
SPL v2
SPL
SPL Set ID bb06559f-fa95-40ce-9639-3a3f051cdd15
Route
TOPICAL
Published
Effective Date 2016-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octinoxate (75 mg) Octisalate (50 mg) Oxybenzone (40 mg)
Inactive Ingredients
Aloe Vera Leaf Carboxypolymethylene Cetyl Alcohol Diethanolamine Cetyl Phosphate Dmdm Hydantoin Iodopropynyl Butylcarbamate Stearic Acid Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-01-15

Description

Homosalate 10.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 4.0%

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 skin aging.

  • For external use only.
Do Not Use

on broken or damaged skin.

Directions:
  • Apply liberally to cool, dry skin 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • For children under 6 months of age: ask a doctor before using.
Stop Use and Ask

a doctor if rash occurs.

Package Labeling:

Other Information:
  • Protect this product container from excessive heat and direct sun.
Active Ingredients:

Homosalate 10.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 4.0%

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Carbomer, Cetyl Alcohol, DEA-Cetyl Phosphate, DMDM

Hydantoin (and) Iodopropynyl Butylcarbamate, Hydrogenated Polyisobutene, Stearic Acid, Triethanolamine, Water.

When Using This Product

keep out of eyes. Rinse with warm water to remove.

Keep Out of Reach of Children.

If 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 skin aging.

  • For external use only.
Do Not Use (Do not use)

on broken or damaged skin.

Directions:
  • Apply liberally to cool, dry skin 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • For children under 6 months of age: ask a doctor before using.
Stop Use and Ask (Stop use and ask)

a doctor if rash occurs.

Package Labeling:

Other Information: (Other information:)
  • Protect this product container from excessive heat and direct sun.
Active Ingredients: (Active ingredients:)

Homosalate 10.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 4.0%

Inactive Ingredients: (Inactive ingredients:)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Carbomer, Cetyl Alcohol, DEA-Cetyl Phosphate, DMDM

Hydantoin (and) Iodopropynyl Butylcarbamate, Hydrogenated Polyisobutene, Stearic Acid, Triethanolamine, Water.

When Using This Product (When using this product)

keep out of eyes. Rinse with warm water to remove.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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