Face Cream 50

Face Cream 50
SPL v1
SPL
SPL Set ID de7eaa27-f8e3-4238-a3a3-2b31d65916e6
Route
TOPICAL
Published
Effective Date 2023-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octisalate (50 mg) Octocrylene (70 mg) Zinc Cation
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Ethylhexyl Palmitate Ethylhexyl Stearate Glycerin Hydrogenated Castor Oil Isoamyl Cocoate Hydrated Silica High Density Polyethylene .alpha.-tocopherol Acetate Aloe Vera Leaf Yellow Wax Hydrogenated Olive Oil Unsaponifiables Sodium Chloride Triethoxycaprylylsilane Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-01-06

Description

Homosalate 10%, Octisalate 5% Octocrylene 10%, Zinc oxide 7%

Purpose

Sunscreen 


Medication Information

Purpose

Sunscreen 

Description

Homosalate 10%, Octisalate 5% Octocrylene 10%, Zinc oxide 7%

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
Warnings

For external use only.

Directions

• shake well before use

• apply liberally 15 minutes before sun exposure

• reapply: • after 80 minutes of swimming or sweating

• immediately after towel drying • at least every 2 hours

• children under 6 months of age: 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 value 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-sleeved shirts, pants, hats and sunglasses

Do Not Use

on damaged or broken skin

Questions?

1-877-978-6286

Other Information

• protect this product from excessive heat and direct sun

• keep outer card for complete directions and warnings

Package Labeling:

Active Ingredients

Homosalate 10%, Octisalate 5%

Octocrylene 10%, Zinc oxide 7%

Inactive Ingredients

water, C12-15 alkyl benzoate, ethylhexyl palmitate, ethylhexyl stearate, cetyl peg/ppg-10/1 dimethicone, glycerin, hydrogenated castor oil, isoamyl cocoate, hydrogenated ethylhexyl olivate, hydrated silica, polyethylene, tocopheryl acetate, theobroma cacao seed butter, aloe barbadensis leaf juice, beeswax, hydrogenated olive oil unsaponifiables, fragrance, sodium chloride, triethoxycaprylysilane, phenoxyethanol, ethylhexylglycerin

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

rash occurs

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.


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
Purpose

Sunscreen 

Warnings

For external use only.

Directions

• shake well before use

• apply liberally 15 minutes before sun exposure

• reapply: • after 80 minutes of swimming or sweating

• immediately after towel drying • at least every 2 hours

• children under 6 months of age: 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 value 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-sleeved shirts, pants, hats and sunglasses

Do Not Use (Do not use)

on damaged or broken skin

Questions?

1-877-978-6286

Other Information

• protect this product from excessive heat and direct sun

• keep outer card for complete directions and warnings

Package Labeling:

Active Ingredients

Homosalate 10%, Octisalate 5%

Octocrylene 10%, Zinc oxide 7%

Inactive Ingredients

water, C12-15 alkyl benzoate, ethylhexyl palmitate, ethylhexyl stearate, cetyl peg/ppg-10/1 dimethicone, glycerin, hydrogenated castor oil, isoamyl cocoate, hydrogenated ethylhexyl olivate, hydrated silica, polyethylene, tocopheryl acetate, theobroma cacao seed butter, aloe barbadensis leaf juice, beeswax, hydrogenated olive oil unsaponifiables, fragrance, sodium chloride, triethoxycaprylysilane, phenoxyethanol, ethylhexylglycerin

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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