Solara (as Pld) - Go! Mineral Defense Sport Antioxidant Face Sunscreen Spf-50 (73054-107)

Solara (as Pld) - Go! Mineral Defense Sport Antioxidant Face Sunscreen Spf-50 (73054-107)
SPL v7
SPL
SPL Set ID f5242c7d-09e1-4141-8de1-a89bd7981ca6
Route
TOPICAL
Published
Effective Date 2021-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (20 g)
Inactive Ingredients
Water Coconut Oil Butyloctyl Salicylate Diheptyl Succinate Methyl Dihydroabietate Butyrospermum Parkii (shea) Butter Unsaponifiables Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Sodium Stearoyl Glutamate Cetostearyl Alcohol Microcrystalline Cellulose Malpighia Glabra Fruit Hyaluronate Sodium Cocoa Butter Glycerin Cetyl Alcohol Levomenol Tocopherol Arachidyl Alcohol Arachidyl Glucoside Docosanol Carboxymethylcellulose Sodium, Unspecified Coco Glucoside Polyhydroxystearic Acid (2300 Mw) Ethylhexylglycerin Phenoxyethanol Sodium Gluconate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-17

Description

Zinc Oxide 20%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20%

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 product is swallowed, get medical help or contact Poison Control Center right away.

Section 51945-4

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 doctor if rash occurs

Directions
  • shake or knead before each use
  • apply generously and evenly 15 minutes before sun exposure
  • reapply:
  • after 40 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 skin aging. To decrease the risk, regularly use asunscreen 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
  • children under 6 months: Ask a doctor
Active Ingredient

Zinc Oxide 20%

Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Water (Aqua), Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Diheptyl Succinate, Methyl Dihydroabietate, Butyrospermum Parkii (Shea) Butter, Capryloyl Glycerin/Sebacic Acid Copolymer, Sodium Stearoyl Glutamate, Cetearyl Alcohol, Microcrystalline Cellulose, Malpighia Glabra (Acerola) Fruit Extract, Sodium Hyaluronate, Theobroma Cacao (Cocoa) Seed Butter, Glycerin, Cetyl Alcohol, Bisabolol, Tocopherol, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Cellulose Gum, Coco-Glucoside, Polyhydroxystearic Acid, Ethylhexylglycerin, Phenoxyethanol, Sodium Gluconate, Citric Acid

Questions Or Comments
  • 1-855-859-1600 (9am – 5pm ET)

Structured Label Content

Uses (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 product is swallowed, get medical help or contact Poison Control Center right away.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Sunscreen

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 doctor if rash occurs

Directions (DIRECTIONS)
  • shake or knead before each use
  • apply generously and evenly 15 minutes before sun exposure
  • reapply:
  • after 40 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 skin aging. To decrease the risk, regularly use asunscreen 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
  • children under 6 months: Ask a doctor
Active Ingredient (ACTIVE INGREDIENT)

Zinc Oxide 20%

Other Information (OTHER INFORMATION)
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients (INACTIVE INGREDIENTS)

Water (Aqua), Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Diheptyl Succinate, Methyl Dihydroabietate, Butyrospermum Parkii (Shea) Butter, Capryloyl Glycerin/Sebacic Acid Copolymer, Sodium Stearoyl Glutamate, Cetearyl Alcohol, Microcrystalline Cellulose, Malpighia Glabra (Acerola) Fruit Extract, Sodium Hyaluronate, Theobroma Cacao (Cocoa) Seed Butter, Glycerin, Cetyl Alcohol, Bisabolol, Tocopherol, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Cellulose Gum, Coco-Glucoside, Polyhydroxystearic Acid, Ethylhexylglycerin, Phenoxyethanol, Sodium Gluconate, Citric Acid

Questions Or Comments (QUESTIONS OR COMMENTS)
  • 1-855-859-1600 (9am – 5pm ET)

Advanced Ingredient Data


Raw Label Data

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