sun protection creme spf 37

sun protection creme spf 37
SPL v3
SPL
SPL Set ID bfcf87c0-27c4-4fba-9f4e-77e7132e073a
Route
topical
Published
Effective Date 2012-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (5 g) octinoxate (7.5 g) octisalate (3 g) oxybenzone titanium dioxide
Inactive Ingredients
water propylene glycol glycerin glyceryl monostearate cetyl alcohol stearic acid dimethicone aloe vera leaf hamamelis virginiana top polysorbate 20 dmdm hydantoin methylparaben propylparaben ferric oxide red ferric oxide yellow ferrosoferric oxide carbomer interpolymer type a (allyl sucrose crosslinked) shea butter xanthan gum .alpha.-tocopherol acetate trolamine butylated hydroxytoluene

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2012-10-15

Description

Active Sunscreen Ingredients Octocrylene (sunscreen) 5,0% Octinoxate (Ethylhexyl Methoxy cinnamate) (sunscreen) 7,5% Octisalate (Ethylhexyl Salicylate) (sunscreen) 5,0% Oxybezone (Benzophenone 3) (sunscreen) 3,0% Titanium Dioxide (sunscreen) 3,0%


Medication Information

Warnings and Precautions

External use only.

Do not use in on damaged or broken skin.

Contains Oxybenzone.

When using this product, keep out of eyes.

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 and not skin cancer and early skin aging.

Limit time in the sun 10 am to 2 p (North Hemisphere).

Wear long-sleeve shirts, pants, hats and sunglasses.

Children should avoid prolonged exposure to sunlight.

Sunscreens do not prevent heat stroke.

Product only available through a professional.

Active Ingredient

Active Sunscreen Ingredients

Octocrylene (sunscreen) 5,0%

Octinoxate (Ethylhexyl Methoxy cinnamate) (sunscreen) 7,5%

Octisalate (Ethylhexyl Salicylate) (sunscreen) 5,0%

Oxybezone (Benzophenone 3) (sunscreen) 3,0%

Titanium Dioxide (sunscreen) 3,0%

Indications and Usage

Stop use if and ask a doctor if rash occurs. If swallowed get medical help or contact a poison control center right away.

Dosage and Administration

How to use

No water resistant product: Apply Liberally 15 minutes before sun exposure.

Reapply at least every two hours. Apply generously before exposure to sun as much as needed. Apply again every 2 hours or immediately after having a bath, energetic activity, excessive perspiration or when using a towel to maintain product effectiveness.

Children under 6 months: ask a doctor.

Protect this product from excessive heat and sunlight.

Description

Active Sunscreen Ingredients Octocrylene (sunscreen) 5,0% Octinoxate (Ethylhexyl Methoxy cinnamate) (sunscreen) 7,5% Octisalate (Ethylhexyl Salicylate) (sunscreen) 5,0% Oxybezone (Benzophenone 3) (sunscreen) 3,0% Titanium Dioxide (sunscreen) 3,0%

Section 50565-1

Keep out of reach of children.

Section 51727-6

INCI Inactive Ingredients

Deionized Water (aqua) * Propylene Glycol * Glycerin * Glyceryl Stearate * Cetyl Alcohol * Stearic Acid * Dimethicone * Aloe Barbadensis (Leaf Extract) * Hamamelis Liquid Extract (Hamamelis Virginiana Extract) * Polysorbate 20 * DMDM Hydantoin

* Methylparaben * propylparaben * Iron Oxides (CI:77.491, CI:77.492, CI 77.499) * Acrylates/C10-30 Alkyl Acrylate Crosspolymer * Shea butter (Butyrospermum Parkii Butter) * Xanthan Gum * Tocopheryl Acetate (vitamin E acetate) * Triethanolamine

* Fragrance (Parfum) * BHT.

Section 51945-4



Exel



Sun Protection Creme SPF

contains Vitamin E Acetate, Shea Butter, and Aloe Vera Gel.

1.69 fl. oz 50

Section 55105-1

Action:

recommend for use in exfoliating treatments with hydroxy acids during summer and, perticularly, when Exel's "Skin Renewal Micro Peel System" is applied.

Helps prevent sunburn

Ultra moisturizing action. Enhanced with Aloe Vera gel, Shea Butter and Vitamin E Acetate.

Dermatologically tested. It does not contain PABA (4-Aminobenzoic Acid).


Structured Label Content

Warnings and Precautions (34071-1)

External use only.

Do not use in on damaged or broken skin.

Contains Oxybenzone.

When using this product, keep out of eyes.

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 and not skin cancer and early skin aging.

Limit time in the sun 10 am to 2 p (North Hemisphere).

Wear long-sleeve shirts, pants, hats and sunglasses.

Children should avoid prolonged exposure to sunlight.

Sunscreens do not prevent heat stroke.

Product only available through a professional.

Active Ingredient (55106-9)

Active Sunscreen Ingredients

Octocrylene (sunscreen) 5,0%

Octinoxate (Ethylhexyl Methoxy cinnamate) (sunscreen) 7,5%

Octisalate (Ethylhexyl Salicylate) (sunscreen) 5,0%

Oxybezone (Benzophenone 3) (sunscreen) 3,0%

Titanium Dioxide (sunscreen) 3,0%

Indications and Usage (34067-9)

Stop use if and ask a doctor if rash occurs. If swallowed get medical help or contact a poison control center right away.

Dosage and Administration (34068-7)

How to use

No water resistant product: Apply Liberally 15 minutes before sun exposure.

Reapply at least every two hours. Apply generously before exposure to sun as much as needed. Apply again every 2 hours or immediately after having a bath, energetic activity, excessive perspiration or when using a towel to maintain product effectiveness.

Children under 6 months: ask a doctor.

Protect this product from excessive heat and sunlight.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

INCI Inactive Ingredients

Deionized Water (aqua) * Propylene Glycol * Glycerin * Glyceryl Stearate * Cetyl Alcohol * Stearic Acid * Dimethicone * Aloe Barbadensis (Leaf Extract) * Hamamelis Liquid Extract (Hamamelis Virginiana Extract) * Polysorbate 20 * DMDM Hydantoin

* Methylparaben * propylparaben * Iron Oxides (CI:77.491, CI:77.492, CI 77.499) * Acrylates/C10-30 Alkyl Acrylate Crosspolymer * Shea butter (Butyrospermum Parkii Butter) * Xanthan Gum * Tocopheryl Acetate (vitamin E acetate) * Triethanolamine

* Fragrance (Parfum) * BHT.

Section 51945-4 (51945-4)



Exel



Sun Protection Creme SPF

contains Vitamin E Acetate, Shea Butter, and Aloe Vera Gel.

1.69 fl. oz 50

Section 55105-1 (55105-1)

Action:

recommend for use in exfoliating treatments with hydroxy acids during summer and, perticularly, when Exel's "Skin Renewal Micro Peel System" is applied.

Helps prevent sunburn

Ultra moisturizing action. Enhanced with Aloe Vera gel, Shea Butter and Vitamin E Acetate.

Dermatologically tested. It does not contain PABA (4-Aminobenzoic Acid).


Advanced Ingredient Data


Raw Label Data

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