Moisturizing Sunscreen Spf 30+

Moisturizing Sunscreen Spf 30+
SPL v6
SPL
SPL Set ID 4b3326a1-b90b-43a4-ba73-c62b3af1f760
Route
TOPICAL
Published
Effective Date 2012-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (8 mL) Octisalate (4 mL) Octinoxate (3 mL)
Inactive Ingredients
Allantoin Caprylyl Glycol Cetostearyl Alcohol Cyclomethicone Edetate Disodium Ethyl Linoleate Lactic Acid Glycerin Polyoxyl 40 Stearate Xanthan Gum Oleyl Alcohol Panthenol Pentylene Glycol Serine Silicon Dioxide Sodium Chloride Sodium Lactate Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-02-17

Description

Active ingredients                   Purpose Homosalate  8%                   Sunscreen Octisalate  4%                      Sunscreen Octinoxate  3%                     Sunscreen Octocrylene  2%                   Sunscreen


Medication Information

Warnings and Precautions

warnings

For external use only

When using this product keep out of eyes. rinse with water to remove

If swallowed, get medical help or call a poison control center right away

Indications and Usage
-Stop use and ask a  doctor if rash or irritation occurs.



-Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce risk of skin aging, skin cancer, and other harmful effects of the sun



-Does not provide protection for already burnt skin



-every case of sunburn damages the skin permanently



-does not provide 100% protection against UV radiation



-store in a cool dry place



-keep carton. It contains important information

Dosage and Administration


Directions



-apply liberally and generously onto clean, dry skin and rub in evenly 20 minutes prior to sun exposure



-apply enough to give a visible layer before rubbing in .



-re-apply as needed every 1-2 hours, or after towel drying, swimming, or perspiring.



-Children under 6 years of age: ask a doctor.

Description

Active ingredients                   Purpose Homosalate  8%                   Sunscreen Octisalate  4%                      Sunscreen Octinoxate  3%                     Sunscreen Octocrylene  2%                   Sunscreen

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive ingredients

Allantoin, Ammonium Acryloyldimethicone/VP copolymer, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Cylcomethicone, Disodium  EDTA, Ethyl Linoleate, Fragrance, Isostearyl Neopentoate, Lactic Acid, Glycerin, Peg-40 Stearate, Polypropylene, Xanthan gum, Octanohydroxamic acid, Oleyl Alcohol, Panthenol, Panthenyl Triacetate, Pentylene Glycol, Serine, Silica, Sodium chloride, Sodium Lactate, Sorbitol, Tocopherol, Triacontanyl PVP, Urea, water.

Section 51945-4


Moisturizing Sunscreen SPF 30+

100 mL/3.4 oz





Section 55105-1

Uses

-Helps prevent sunburn

-higher SPF gives more sunburn protection

-provides high protection against sunburn

-for skin highly sensitive to sunburn

Section 55106-9

Active ingredients                   Purpose

Homosalate  8%                   Sunscreen

Octisalate  4%                      Sunscreen

Octinoxate  3%                     Sunscreen

Octocrylene  2%                   Sunscreen


Structured Label Content

Indications and Usage (34067-9)
-Stop use and ask a  doctor if rash or irritation occurs.



-Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce risk of skin aging, skin cancer, and other harmful effects of the sun



-Does not provide protection for already burnt skin



-every case of sunburn damages the skin permanently



-does not provide 100% protection against UV radiation



-store in a cool dry place



-keep carton. It contains important information

Dosage and Administration (34068-7)


Directions



-apply liberally and generously onto clean, dry skin and rub in evenly 20 minutes prior to sun exposure



-apply enough to give a visible layer before rubbing in .



-re-apply as needed every 1-2 hours, or after towel drying, swimming, or perspiring.



-Children under 6 years of age: ask a doctor.

Warnings and Precautions (34071-1)

warnings

For external use only

When using this product keep out of eyes. rinse with water to remove

If swallowed, get medical help or call a poison control center right away

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive ingredients

Allantoin, Ammonium Acryloyldimethicone/VP copolymer, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Cylcomethicone, Disodium  EDTA, Ethyl Linoleate, Fragrance, Isostearyl Neopentoate, Lactic Acid, Glycerin, Peg-40 Stearate, Polypropylene, Xanthan gum, Octanohydroxamic acid, Oleyl Alcohol, Panthenol, Panthenyl Triacetate, Pentylene Glycol, Serine, Silica, Sodium chloride, Sodium Lactate, Sorbitol, Tocopherol, Triacontanyl PVP, Urea, water.

Section 51945-4 (51945-4)


Moisturizing Sunscreen SPF 30+

100 mL/3.4 oz





Section 55105-1 (55105-1)

Uses

-Helps prevent sunburn

-higher SPF gives more sunburn protection

-provides high protection against sunburn

-for skin highly sensitive to sunburn

Section 55106-9 (55106-9)

Active ingredients                   Purpose

Homosalate  8%                   Sunscreen

Octisalate  4%                      Sunscreen

Octinoxate  3%                     Sunscreen

Octocrylene  2%                   Sunscreen


Advanced Ingredient Data


Raw Label Data

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