Superscreen Hydrating Daily Cream Spf 40

Superscreen Hydrating Daily Cream Spf 40
SPL v1
SPL
SPL Set ID ff0e4e97-8f01-bd36-e053-6394a90a47ae
Route
TOPICAL
Published
Effective Date 2023-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (6 g) Octocrylene (1.5 g) Avobenzone (3 g) Octisalate (5 g)
Inactive Ingredients
Carthamus Tinctorius (safflower) Oleosomes Alkyl (c12-15) Benzoate Ectoine Medium-chain Triglycerides Glyceryl Trioleate Inulin Lauryl Carbamate Water Polyester-7 Ammonium Acryloyldimethyltaurate/vp Copolymer Hydroxyacetophenone Chlorphenesin Aphanizomenon Flosaquae Glyceryl Dioleate Neopentyl Glycol Diheptanoate Diethylhexyl Syringylidenemalonate Ceramide Np Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-06-26

Description

Active Ingredients: Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 1.5%


Medication Information

Warnings and Precautions

For External use only

Do not use 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 generously and evenly 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

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

Children under 6 months: Ask a doctor

Description

Active Ingredients: Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 1.5%

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

Superscreen Hydrating Daily Cream SPF 40 / 50 mL

Section 55105-1

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 55106-9

Active Ingredients: Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 1.5%


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

Apply generously and evenly 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

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

Children under 6 months: Ask a doctor

Warnings and Precautions (34071-1)

For External use only

Do not use 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 51945-4 (51945-4)

Superscreen Hydrating Daily Cream SPF 40 / 50 mL

Section 55105-1 (55105-1)

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 55106-9 (55106-9)

Active Ingredients: Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 1.5%


Advanced Ingredient Data


Raw Label Data

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