spf50 sunscreen stick

spf50 sunscreen stick
SPL v1
SPL
SPL Set ID 1938fa13-875a-140e-e063-6294a90a5514
Route
topical
Published
Effective Date 2024-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (10 g) homosalate (15 g) octisalate (5 g) avobenzone (3 g)
Inactive Ingredients
c15-19 alkane ethylhexyl palmitate caprylic/capric/lauric triglyceride sunflower oil cocoa butter butylated hydroxytoluene cetyl alcohol aloe paraffin alkyl (c12-15) benzoate vinylpyrrolidone/eicosene copolymer polyester-8 (1400 mw, cyanodiphenylpropenoyl capped)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-10-16

Purpose

Sunscreen

Description

Zinc Oxide 21.6% ................Sunscreen


Medication Information

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

Directions

apply liberally 15 minutes before sun exposure. Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours.  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 of age: ask a doctor

Other Information

protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Adipic Acid/Diglycol Crosspolymer, C12-15 Alkyl Benzoate,

Caprylyl Glycol, Isopropyl Myristate, Neopentyl Glycol

Diethylhexanoate, Neopentyl Glycol Diisostearate,

Octyldodecyl Neopentanoate, Ozokerite, Paraffin, Silica,

Synthetic Wax, Tocopheryl Acetate, Triethoxycaprylylsilane

Description

Zinc Oxide 21.6% ................Sunscreen

Section 51945-4

Do Not Use On

damaged or broken skin

When Using This Product

keep out of eyes. Rinse eyes with water to remove

Stop Use and Ask A Doctor If

• rash or irritation develops and lasts

Keep Out of the Reach of Children

If product is swallowed, get medical help or contact a Poison Control Center right away

Active                                    Ingredient

Zinc Oxide 21.6% ................Sunscreen


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

Directions

apply liberally 15 minutes before sun exposure. Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours.  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 of age: ask a doctor

Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Adipic Acid/Diglycol Crosspolymer, C12-15 Alkyl Benzoate,

Caprylyl Glycol, Isopropyl Myristate, Neopentyl Glycol

Diethylhexanoate, Neopentyl Glycol Diisostearate,

Octyldodecyl Neopentanoate, Ozokerite, Paraffin, Silica,

Synthetic Wax, Tocopheryl Acetate, Triethoxycaprylylsilane

Section 51945-4 (51945-4)

Do Not Use On (Do not use on)

damaged or broken skin

When Using This Product (When using this product)

keep out of eyes. Rinse eyes with water to remove

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

• rash or irritation develops and lasts

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

If product is swallowed, get medical help or contact a Poison Control Center right away

Active                                    Ingredient (Active                                    ingredient)

Zinc Oxide 21.6% ................Sunscreen


Advanced Ingredient Data


Raw Label Data

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