spf 30 sunscreen lotion

spf 30 sunscreen lotion
SPL v4
SPL
SPL Set ID 569b8010-d2bb-4eda-90de-9ef8950823e2
Route
topical
Published
Effective Date 2017-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (75 mg) octisalate (20 mg) oxybenzone (40 mg) titanium dioxide (25 mg)
Inactive Ingredients
water cetostearyl alcohol xanthan gum alkyl (c12-15) benzoate myristyl propionate propylene glycol glyceryl stearate citrate edetate disodium anhydrous iodopropynyl butylcarbamate dmdm hydantoin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-07-22

Purpose

Sunscreen

Description

Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0%  Titanium Dioxide 2.5%


Medication Information

Uses

• Helps prevent sunburn

Purpose

Sunscreen

Directions

Apply generously & evenly before sun exposure.Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Cetearyl Alcohol, Xanthan Gum, C12-15 Alkyl Benzoate, Myristyl Propionate, Propylene Glycol, Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl Butylcarbamate, DMDM Hydantoin, Fragrance.

Description

Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0%  Titanium Dioxide 2.5%

Warnings:

Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging.

This products has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do Not Use

on damaged or broken skin.

Distributed By:

Tekweld: 45 Rabro Drive, Hauppauge, NY11788

Package Labeling:

Active Ingredients

Octinoxate 7.5%,

Octisalate 2.0%,

Oxybenzone 4.0% 

Titanium Dioxide 2.5%

Questions Or Comment ?

Call toll free 1-877-254-2281

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


Structured Label Content

Uses

• Helps prevent sunburn

Purpose

Sunscreen

Directions

Apply generously & evenly before sun exposure.Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

Other Information (Other information)

Protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Cetearyl Alcohol, Xanthan Gum, C12-15 Alkyl Benzoate, Myristyl Propionate, Propylene Glycol, Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl Butylcarbamate, DMDM Hydantoin, Fragrance.

Warnings: (WARNINGS:)

Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging.

This products 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 damaged or broken skin.

Distributed By:

Tekweld: 45 Rabro Drive, Hauppauge, NY11788

Package Labeling:

Active Ingredients

Octinoxate 7.5%,

Octisalate 2.0%,

Oxybenzone 4.0% 

Titanium Dioxide 2.5%

Questions Or Comment ? (Questions or Comment ?)

Call toll free 1-877-254-2281

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


Advanced Ingredient Data


Raw Label Data

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