Sun Shades Mineral Plus Spf 30+ Sunscreen

Sun Shades Mineral Plus Spf 30+ Sunscreen
SPL v8
SPL
SPL Set ID 8886cbd0-ed2b-4a2b-a724-a0d4f12296c9
Route
TOPICAL
Published
Effective Date 2013-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (9.225 g) Octocrylene (5.535 g) Zinc Oxide (18.45 g)
Inactive Ingredients
Neopentyl Glycol Diheptanoate Pentylene Glycol Phenoxyethanol Phenyl Trimethicone Potassium Cetyl Phosphate Potassium Sorbate Sheanut Oil Sodium Chloride Sucrose Distearate .alpha.-tocopherol Acetate Water Xanthan Gum Yellow Wax Sodium Hydroxide Alkyl (c12-15) Benzoate Ascorbyl Palmitate Ceteth-10 Phosphate Cetostearyl Alcohol Cetyl Alcohol Dicaprylyl Carbonate Dihexadecyl Phosphate Disodium Lauriminodipropionate Tocopheryl Phosphates Glycerin Hydrogenated Palm Glycerides Isoeicosane Isostearic Acid Kukui Nut Oil Levomenol Macadamia Oil Medium-chain Triglycerides Trisodium Ethylenediamine Disuccinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-12-27

Description

Octisalate 5%, Octocrylene 3%, Zinc Oxide 10.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octisalate 5%, Octocrylene 3%, Zinc Oxide 10.5%

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

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 51945-4

Warnings

For external use only

Directions

■ apply liberally and spread evenly by hand 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 signs of 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 AM-2 PM

■ wear long-sleeve shirts, pants, hats, and sunglasses

■ children under 6 months of age: ask a doctor

Other Information

■ protect this product from excessive heat and direct sun

■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Active Ingredients

Octisalate 5%, Octocrylene 3%, Zinc Oxide 10.5%

Inactive Ingredients

water (aqua/eau), caprylic/capric triglyceride, cetearyl alcohol, isoeicosane, C12-15 alkyl benzoate, glycerin, dicaprylyl carbonate, polyester-7, butyrospermum parkii (shea) butter, pentylene glycol, phenyl trimethicone, phenoxyethanol, neopentyl glycol diheptanoate, beeswax (cera alba), ceteth-10 phosphate, dicetyl phosphate, sucrose distearate, aleurites moluccana seed oil, cetyl alcohol, sodium chloride, potassium cetyl phosphate, xanthan gum, fragrance (parfum), potassium sorbate, isostearic acid, lecithin, polyglyceryl-3 polyricinoleate, polyhydroxystearic acid, hydrogenated palm glycerides, trisodium ethylenediamine disuccinate, bisabolol, disodium lauriminodipropionate tocopheryl phosphates, macadamia ternifolia seed oil, sodium hydroxide, ascorbyl palmitate, tocopheryl acetate, benzyl salicylate, coumarin, linalool


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 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 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

■ apply liberally and spread evenly by hand 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 signs of 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 AM-2 PM

■ wear long-sleeve shirts, pants, hats, and sunglasses

■ children under 6 months of age: ask a doctor

Other Information (Other information)

■ protect this product from excessive heat and direct sun

■ do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

Active Ingredients (Active ingredients)

Octisalate 5%, Octocrylene 3%, Zinc Oxide 10.5%

Inactive Ingredients (Inactive ingredients)

water (aqua/eau), caprylic/capric triglyceride, cetearyl alcohol, isoeicosane, C12-15 alkyl benzoate, glycerin, dicaprylyl carbonate, polyester-7, butyrospermum parkii (shea) butter, pentylene glycol, phenyl trimethicone, phenoxyethanol, neopentyl glycol diheptanoate, beeswax (cera alba), ceteth-10 phosphate, dicetyl phosphate, sucrose distearate, aleurites moluccana seed oil, cetyl alcohol, sodium chloride, potassium cetyl phosphate, xanthan gum, fragrance (parfum), potassium sorbate, isostearic acid, lecithin, polyglyceryl-3 polyricinoleate, polyhydroxystearic acid, hydrogenated palm glycerides, trisodium ethylenediamine disuccinate, bisabolol, disodium lauriminodipropionate tocopheryl phosphates, macadamia ternifolia seed oil, sodium hydroxide, ascorbyl palmitate, tocopheryl acetate, benzyl salicylate, coumarin, linalool


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)