american crew all in one face balm

american crew all in one face balm
SPL v3
SPL
SPL Set ID 012be422-1b4c-443c-9484-02efc744296d
Route
topical
Published
Effective Date 2017-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (5 mg) homosalate (2 mg) avobenzone octocrylene
Inactive Ingredients
alkyl (c12-15) benzoate squalane glycerin dimethicone cetostearyl alcohol behentrimonium chloride polyquaternium-37 (10000 mpa.s) .alpha.-bisabolol, (+/-)- dexpanthenol 4-hydroxy acetophenone glyceryl dibehenate allantoin caprylyl glycol 1,2-hexanediol .alpha.-tocopherol acetate tribehenin farnesol edetate disodium anhydrous sodium citrate, unspecified form glycyrrhizinate dipotassium phenoxyethanol saccharide isomerate hydroxycitronellal benzyl salicylate limonene, (+)- linalool, (+/-)- .beta.-citronellol, (r)- eugenol geraniol benzyl benzoate citral cinnamyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-04-01

Purpose

Sunscreen

Description

Octisalate 5.0% Homosalate 5.0% Avobenzone 2.0% Octocrylene 2.0%


Medication Information

Warnings

•For external use only

•Do notuse on damaged or broken skin

•When using this product: Keep out of eyes. Rinse with water to remove.

•Stop use and ask a doctor if a rash occurs

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

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

caused by the sun.

Purpose

Sunscreen

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Directions

•Apply liberally 15 minutes before sun exposure

•Use a water resistant sunscreen if swimming or sweating

•Reapply at least every 2 hours

•Children under 6 months: Ask a doctor.

Inactive Ingredients

Aqua/Water/Eau, C12-15 Alkyl Benzoate, Squalane,

Glycerin, Dimethicone, Cetearyl Alcohol, Behentrimonium

Chloride, Polyquaternium-37, Bisabolol, Panthenol,

Hydroxyacetophenone, Glyceryl Dibehenate, Allantoin,

Tocopheryl Acetate, Tribehenin, Glyceryl Behenate,

Farnesol, Disodium EDTA, Sodium Citrate, Dipotassium

Glycyrrhizate, Dimethicone Crosspolymer, Saccharide

Isomerate, Parfum (Fragrance), Caprylyl Glycol,

1,2-Hexanediol, Phenoxyethanol, Hydroxycitronellal,

Description

Octisalate 5.0% Homosalate 5.0% Avobenzone 2.0% Octocrylene 2.0%

Questions?

1-800-598-2739

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 51945-4

American Crew All in One Face Balm

Broad Spectrum SPF 15

170mL

Active Ingredients

Octisalate 5.0%

Homosalate 5.0%

Avobenzone 2.0%

Octocrylene 2.0%

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 value of 15 or higher and other sun protection measures including:

•Limit time in the sun, especially from 10 am - 2 pm

•Wear long-sleeved shirts, pants, hats and sunglasses.


Structured Label Content

Warnings

•For external use only

•Do notuse on damaged or broken skin

•When using this product: Keep out of eyes. Rinse with water to remove.

•Stop use and ask a doctor if a rash occurs

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

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

caused by the sun.

Purpose

Sunscreen

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure

Directions

•Apply liberally 15 minutes before sun exposure

•Use a water resistant sunscreen if swimming or sweating

•Reapply at least every 2 hours

•Children under 6 months: Ask a doctor.

Inactive Ingredients

Aqua/Water/Eau, C12-15 Alkyl Benzoate, Squalane,

Glycerin, Dimethicone, Cetearyl Alcohol, Behentrimonium

Chloride, Polyquaternium-37, Bisabolol, Panthenol,

Hydroxyacetophenone, Glyceryl Dibehenate, Allantoin,

Tocopheryl Acetate, Tribehenin, Glyceryl Behenate,

Farnesol, Disodium EDTA, Sodium Citrate, Dipotassium

Glycyrrhizate, Dimethicone Crosspolymer, Saccharide

Isomerate, Parfum (Fragrance), Caprylyl Glycol,

1,2-Hexanediol, Phenoxyethanol, Hydroxycitronellal,

Questions?

1-800-598-2739

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 51945-4 (51945-4)

American Crew All in One Face Balm

Broad Spectrum SPF 15

170mL

Active Ingredients

Octisalate 5.0%

Homosalate 5.0%

Avobenzone 2.0%

Octocrylene 2.0%

Sun Protection Measures (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 value of 15 or higher and other sun protection measures including:

•Limit time in the sun, especially from 10 am - 2 pm

•Wear long-sleeved shirts, pants, hats and sunglasses.


Advanced Ingredient Data


Raw Label Data

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