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

Description

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

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 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

Warnings

For external use only

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

Active Ingredients

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

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)


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

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)

Purpose

Sunscreen

Warnings

For external use only

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

Active Ingredients (Active ingredients)

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

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)


Advanced Ingredient Data


Raw Label Data

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