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

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Description

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

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.

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

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

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.

Questions?

1-800-598-2739

Active Ingredients

Octisalate 5.0%

Homosalate 5.0%

Avobenzone 2.0%

Octocrylene 2.0%

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,

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

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.

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure

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

Purpose

Sunscreen

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

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.

Questions?

1-800-598-2739

Active Ingredients

Octisalate 5.0%

Homosalate 5.0%

Avobenzone 2.0%

Octocrylene 2.0%

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,

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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