sun shades lip balm - sunscreen

sun shades lip balm - sunscreen
SPL v3
SPL
SPL Set ID 66103b86-7470-4f53-aade-b8028bc9b514
Route
topical
Published
Effective Date 2013-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (0.1175 g) octinoxate (0.282 g) oxybenzone (0.141 g)
Inactive Ingredients
alkyl (c12-15) benzoate alpha-tocopherol acetate ammonium glycyrrhizate ceresin cetyl esters wax cocoa butter ethylene-vinyl acetate copolymer (40% vinyl acetate) jojoba oil petrolatum yellow wax candelilla wax

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2012-08-01

Purpose

Sunscreen

Description

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%


Medication Information

Warnings

For external use only

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 at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating ■ 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-sleeve shirts, pants, hats, and sunglasses

Other Information

■ dermatologist and allergy tested

Inactive Ingredients

ammonium glycyrrhizate, beeswax, C12-15 alkyl benzoate, cetyl esters, ethylene/VA copolymer, euphorbia cerifera (candillia) wax, flavor petrolatum USP, simmondsia chinensis (jojoba) seed oil, stearyl dimethicone, theobroma cacao (cocoa) seed butter, tocopheryl acetate (vitamin E USP)

Description

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

Section 44425-7

■ protect this product from excessive heat and direct sun ■ do not store at temperatures below 32 F (0C) or above 120F (48C)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a dcotor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 51945-4

Active Ingredients

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%


Structured Label Content

Warnings

For external use only

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 at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating ■ 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-sleeve shirts, pants, hats, and sunglasses

Other Information (Other information)

■ dermatologist and allergy tested

Inactive Ingredients

ammonium glycyrrhizate, beeswax, C12-15 alkyl benzoate, cetyl esters, ethylene/VA copolymer, euphorbia cerifera (candillia) wax, flavor petrolatum USP, simmondsia chinensis (jojoba) seed oil, stearyl dimethicone, theobroma cacao (cocoa) seed butter, tocopheryl acetate (vitamin E USP)

Section 44425-7 (44425-7)

■ protect this product from excessive heat and direct sun ■ do not store at temperatures below 32 F (0C) or above 120F (48C)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a dcotor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51945-4 (51945-4)

Active Ingredients (Active ingredients)

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%


Advanced Ingredient Data


Raw Label Data

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