Sunscreen Spf 50

Sunscreen Spf 50
SPL v4
SPL
SPL Set ID 9bf66460-1835-4135-b4be-016ffdabe9a8
Route
TOPICAL
Published
Effective Date 2013-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g) Octocrylene Oxybenzone
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Allantoin Aluminum Starch Octenylsuccinate Arachidyl Alcohol Arachidyl Glucoside Arginine Docosanol Levomenol Chlorphenesin Cyclomethicone 5 Edetate Disodium Ethylhexylglycerin Glyceryl Monostearate Lauroyl Lysine Methylisothiazolinone Mica Silicon Dioxide Panthenol Peg-100 Stearate .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-02-19

Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 10% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen Oxybenzone 5% Sunscreen


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use on on damaged or broken skin

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

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least ever 2 hours, especially if swimming, sweating, or after toweling

children under 6 months: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m.-2 p.m.

wear long-sleeve shirts, pants, hats, and sunglasses

Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 10% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen Oxybenzone 5% Sunscreen

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Bisabolol, Chlorphenesin, Cyclopentasiloxane, Disodium EDTA, Ethylhexylglycerin, Fragrance/parfum, Glyceryl Stearate, Lauroyl Lysine, Methylisothiazolinone, Mica, Silica, Panthenol, PEG-100 Stearate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water/Aqua.

Section 51945-4

Jafra Sun

50+

Sunscreen Cream Broad Spectrum SPF 50+

UVA/UVB Protection

125 ml 4.2 Fl Oz. (US)

Section 55105-1

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging by the sun

Section 55106-9

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

Oxybenzone 5% Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least ever 2 hours, especially if swimming, sweating, or after toweling

children under 6 months: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m.-2 p.m.

wear long-sleeve shirts, pants, hats, and sunglasses

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use on on damaged or broken skin

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

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Bisabolol, Chlorphenesin, Cyclopentasiloxane, Disodium EDTA, Ethylhexylglycerin, Fragrance/parfum, Glyceryl Stearate, Lauroyl Lysine, Methylisothiazolinone, Mica, Silica, Panthenol, PEG-100 Stearate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water/Aqua.

Section 51945-4 (51945-4)

Jafra Sun

50+

Sunscreen Cream Broad Spectrum SPF 50+

UVA/UVB Protection

125 ml 4.2 Fl Oz. (US)

Section 55105-1 (55105-1)

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging by the sun

Section 55106-9 (55106-9)

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

Oxybenzone 5% Sunscreen


Advanced Ingredient Data


Raw Label Data

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