Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f0fb1b69-53f2-efff-e053-2995a90af9d4
Route
TOPICAL
Published
Effective Date 2022-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (9.3 g) Homosalate (10 g)
Inactive Ingredients
Apple Peel Arabidopsis Thaliana Clove Leaf Oil Ergothioneine Phenoxyethanol Sodium Citrate Ammonium Acryloyl Dimethyltaurate/methacrylate, Dimethylacrylamide And Methacrylic Acid Copolymer, Ppg-3 Glyceryl Triacrylate Crosslinked (100000 Mw) Dimethicone/peg-10/15 Crosspolymer Caprylyl Trisiloxane Ethylhexylglycerin Candelilla Wax Anhydrous Dextrose Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Glycerin Xanthan Gum Edetate Disodium Anhydrous Eugenol Sheanut Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Isodecyl Neopentanoate Tetrahexyldecyl Ascorbate Hyaluronate Sodium .alpha.-tocopherol Acetate Lecithin, Soybean Sodium Chloride Peg-8/smdi Copolymer Homarine Hydrochloride Sodium Succinate Anhydrous P-methylaminophenol Sulfate Dimethicone Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Polyisobutylene (55000 Mw) Polysorbate 20 Panthenol Sorbitan Isostearate Mandarin Oil Dipropylene Glycol Tocopherol Sodium Benzoate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Potassium Sorbate Orange Oil Micrococcus Luteus Water Cyclomethicone 5 Limonene, (+)- Cetearyl Methicone (15000 Mw) Erythritol Pea Protein

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-29

Description

Active ingredients Homosalate 10% Zinc Oxide 9.3%


Medication Information

Warnings and Precautions

Warnings :

For external use only

Indications and Usage

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

Dosage and Administration

Directions • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • 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

Description

Active ingredients Homosalate 10% Zinc Oxide 9.3%

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 doctor 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 51727-6

Inactive ingredients AQUA/WATER/EAU, CYCLOPENTASILOXANE, ISODECYL NEOPENTANOATE, GLYCERIN, DIMETHICONE, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYROSPERMUM PARKII (SHEA) NUT EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) OIL, LIMONENE, POLYACRYLATE-13, DIMETHICONE/PEG-10/15 CROSSPOLYMER, CAPRYLYL METHICONE, PHENOXYETHANOL, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYISOBUTENE, CETEARYL DIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, EUPHORBIA CERIFERA (CANDELILLA) CERA/EUPHORBIA CERIFERA (CANDELILLA) WAX, XANTHAN GUM, POLYSORBATE 20, ETHYLHEXYLGLYCERIN, PANTHENOL, SORBITAN ISOSTEARATE, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, DISODIUM EDTA, EUGENIA CARYOPHYLLUS (CLOVE) LEAF OIL, DIPROPYLENE GLYCOL, ERYTHRITOL, EUGENOL, SODIUM CITRATE, GLUCOSE, HYDROLYZED PEA PROTEIN, SODIUM CHLORIDE, TOCOPHEROL, PEG-8/SMDI COPOLYMER, TETRAHEVLDECYL ASCORBATE, TOCOPHERYL ACETATE, SODIUM HYALURONATE, POTASSIUM SORBATE, SODIUM BENZOATE, LECITHIN, HOMARINE HCL, SODIUM SUCCINATE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, MALUS DOMESTICA FRUIT CELL CULTURE EXTRACT, ARABIDOPSIS THALIANA EXTRACT, MICROCOCCUS LYSATE, PLANKTON EXTRACT, ERGOTHIONEINE.

Section 51945-4

Section 55105-1

Purpose:

Sunscreen

Section 55106-9

Active ingredients

Homosalate 10%

Zinc Oxide 9.3%

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • 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

Warnings and Precautions (34071-1)

Warnings :

For external use only

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 doctor 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 51727-6 (51727-6)

Inactive ingredients AQUA/WATER/EAU, CYCLOPENTASILOXANE, ISODECYL NEOPENTANOATE, GLYCERIN, DIMETHICONE, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYROSPERMUM PARKII (SHEA) NUT EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) OIL, LIMONENE, POLYACRYLATE-13, DIMETHICONE/PEG-10/15 CROSSPOLYMER, CAPRYLYL METHICONE, PHENOXYETHANOL, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYISOBUTENE, CETEARYL DIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, EUPHORBIA CERIFERA (CANDELILLA) CERA/EUPHORBIA CERIFERA (CANDELILLA) WAX, XANTHAN GUM, POLYSORBATE 20, ETHYLHEXYLGLYCERIN, PANTHENOL, SORBITAN ISOSTEARATE, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, DISODIUM EDTA, EUGENIA CARYOPHYLLUS (CLOVE) LEAF OIL, DIPROPYLENE GLYCOL, ERYTHRITOL, EUGENOL, SODIUM CITRATE, GLUCOSE, HYDROLYZED PEA PROTEIN, SODIUM CHLORIDE, TOCOPHEROL, PEG-8/SMDI COPOLYMER, TETRAHEVLDECYL ASCORBATE, TOCOPHERYL ACETATE, SODIUM HYALURONATE, POTASSIUM SORBATE, SODIUM BENZOATE, LECITHIN, HOMARINE HCL, SODIUM SUCCINATE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, MALUS DOMESTICA FRUIT CELL CULTURE EXTRACT, ARABIDOPSIS THALIANA EXTRACT, MICROCOCCUS LYSATE, PLANKTON EXTRACT, ERGOTHIONEINE.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Homosalate 10%

Zinc Oxide 9.3%

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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