Spf 50 Stay Put Sunscreen

Spf 50 Stay Put Sunscreen
SPL v2
SPL
SPL Set ID 3beea0c2-6093-48c8-8e9f-a4914bb6570a
Route
TOPICAL
Published
Effective Date 2016-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Octisalate (50 mg) Oxybenzone (60 mg) Titanium Dioxide (26 mg)
Inactive Ingredients
Aloe Vera Leaf Dioctyl Maleate Neopentyl Glycol Diethylhexanoate Neopentyl Glycol Diisostearate Octyldodecyl Neopentanoate Peg-30 Dipolyhydroxystearate Phenoxyethanol Methylparaben Ethylparaben Butylparaben Propylparaben Isobutylparaben High Density Polyethylene Propylene Glycol Dicaprylate Propylene Glycol Dicaprate Ppg-1 Trideceth-6 Water

Identifiers & Packaging

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

Description

Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 6.0%, Titanium Dioxide 2.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 6.0%, Titanium Dioxide 2.6%

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.

Other Information:

· Protect this product container from excessive heat and direct sun.

Active Ingredients:

Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 6.0%, Titanium Dioxide 2.6%

​package Labeling:

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Dicaprylyl Maleate, Neopentyl Glycol Diethylhexanoate (and) Neopentyl Glycol Diisostearate, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Phenoxyethanol (and) Methylparaben (and) Ethylparaben (and) Butylparaben (and)  Propylparaben (and) Isobutylparaben, Polyethylene, Polyquaternium 37 (and) Propylene Glycol Dicaprylate/Dicaprate (and) PPG-1 Trideceth-6, Water

When Using This Product

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

Stop Use and Ask A Doctor

if rash occurs.

​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.

Other Information: (Other information:)

· Protect this product container from excessive heat and direct sun.

Active Ingredients: (Active ingredients:)

Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 6.0%, Titanium Dioxide 2.6%

​package Labeling: (​Package Labeling:)

Inactive Ingredients: (Inactive ingredients:)

Aloe Barbadensis Leaf Juice, Dicaprylyl Maleate, Neopentyl Glycol Diethylhexanoate (and) Neopentyl Glycol Diisostearate, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Phenoxyethanol (and) Methylparaben (and) Ethylparaben (and) Butylparaben (and)  Propylparaben (and) Isobutylparaben, Polyethylene, Polyquaternium 37 (and) Propylene Glycol Dicaprylate/Dicaprate (and) PPG-1 Trideceth-6, Water

When Using This Product (When using this product)

keep out of eyes. Rinse with warm 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 swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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