Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID dbb8df99-69a5-471c-bd75-296c7acaf112
Route
TOPICAL
Published
Effective Date 2019-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g)
Inactive Ingredients
Water Butyloctyl Salicylate Dipropylene Glycol Caprylyl Caprylate Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate Propanediol Hydrogenated Polybutene (1300 Mw) Methyl Dihydroabietate Ammonium Acryloyldimethyltaurate/vp Copolymer Polyamide-3 (12000 Mw) Silicon Glycerin .alpha.-tocopherol Acetate Saccharide Isomerate Disodium Edta-copper Sodium Hydroxide Aloe Vera Leaf Sucrose Panax Quinquefolius Whole Lecithin, Sunflower Benzyl Alcohol Ethylhexylglycerin Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-07-06

Description

Avobenzone 3% Homosalate 10% Octisalate 5%


Medication Information

Description

Avobenzone 3% Homosalate 10% Octisalate 5%

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

Do not use on damaged or broken skin

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

Stop use and ask a docor if rash occurs

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

Directions

• apply generously 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 of age: Ask a doctor

Other Information

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

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Inactive Ingredients

Water/Aqua/Eau, Butyloctyl Salicylate, Dipropylene Glycol, Caprylyl Methicone, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Propanediol, Hydrogenated Polyisobutene, Acrylates Copolymer, Methyl Dihydroabietate, Ammonium Acry loyldimethyltaurate/P Copolymer, Polyamide-1, Silica, Glycerin, Tocopheryl Acetate, Saccharide Isomerate, Disodium EDTA, Dipotassium Glycyrrhizate, Sodium Hydroxide, Aloe Barbadensis Leaf Juice, Sucrose, Panax Quinquefolius Root Extract, Plankton Extract, Lecithin, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol

Questions Or Comments?

Call toll-free 1-877-275-6561 or visit www.bravosierra.com

Principal Display Panel


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

Warnings

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.

Stop use and ask a docor if rash occurs

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

Directions

• apply generously 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 of age: Ask a doctor

Other Information

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

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Inactive Ingredients (Inactive ingredients)

Water/Aqua/Eau, Butyloctyl Salicylate, Dipropylene Glycol, Caprylyl Methicone, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Propanediol, Hydrogenated Polyisobutene, Acrylates Copolymer, Methyl Dihydroabietate, Ammonium Acry loyldimethyltaurate/P Copolymer, Polyamide-1, Silica, Glycerin, Tocopheryl Acetate, Saccharide Isomerate, Disodium EDTA, Dipotassium Glycyrrhizate, Sodium Hydroxide, Aloe Barbadensis Leaf Juice, Sucrose, Panax Quinquefolius Root Extract, Plankton Extract, Lecithin, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol

Questions Or Comments? (Questions or Comments?)

Call toll-free 1-877-275-6561 or visit www.bravosierra.com

Principal Display Panel


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)