spf 30 daily sunscreen

spf 30 daily sunscreen
SPL v8
SPL
SPL Set ID c0541f32-f072-3630-e053-2a95a90a12d6
Route
topical
Published
Effective Date 2021-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (220 mg)
Inactive Ingredients
water medium-chain triglycerides dicaprylyl carbonate coconut alkanes glyceryl monostearate caramel glycerin silicon dioxide peg-100 stearate polyhydroxystearic acid (2300 mw) dimethicone glyceryl stearate citrate polymethylsilsesquioxane (4.5 microns) potassium cetyl phosphate stearic acid phenoxyethanol polyglyceryl-3 stearate cocoyl caprylocaprate sodium stearoyl glutamate hydrogenated soybean lecithin hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) dimethicone/vinyl dimethicone crosspolymer (soft particle) squalane levomenol shea butter .alpha.-tocopherol acetate xanthan gum citric acid monohydrate aloe vera leaf ethylhexylglycerin panthenol polysorbate 60 trisodium ethylenediamine disuccinate 1,2-hexanediol tocopherol ascorbyl palmitate sorbitan isostearate biosaccharide gum-4 sunflower oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-04-19

Purpose

Sunscreen

Description

Zinc Oxide 22%


Medication Information

Warnings

only External use

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
Purpose

Sunscreen

Directions
  • apply liberally and evenly 15 minutes before sun exposure 
  • reapply at least every 2 hours 
  • use a water-resistant sunscreen if swimming or sweating 
  • 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”  “Sun Protection Measures.



  • Children under 6 months of age: Ask a doctor
Other Information

Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Coconut Alkanes, Glyceryl Stearate, Caramel, Glycerin, Silica, PEG-100 Stearate, Polyhydroxystearic Acid, Dimethicone, Glyceryl Stearate Citrate, Polymethylsilsesquioxane/Silica Crosspolymer, Potassium Cetyl Phosphate, Stearic Acid, Phenoxyethanol, Polyglyceryl-3 Stearate, Coco-Caprylate/Caprate, Sodium Stearoyl Glutamate, Hydrogenated Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysilicone-11, Squalane, Bisabolol, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Xanthan Gum, Citric Acid,Aloe Barbadensis Leaf Juice Powder, Ethylhexylglycerin, Panthenol, Lecithin, Polysorbate 60, Trisodium Ethylenediamine Disuccinate, 1,2-Hexanediol, Tocopherol, Ascorbyl Palmitate, Sorbitan Isostearate, Biosaccharide Gum-4, Helianthus Annuus (Sunflower) Seed Oil.

Description

Zinc Oxide 22%

Do Not Use
  • on damaged or broken skin.
Drug Facts

Package Labeling:

Active Ingredients

Zinc Oxide 22%

Questions Or Comments?

Call toll free (833) 981-2335

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor
  • if rash occurs
Keep Out of Reach of Children.
  • If product is swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

only External use

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
Purpose

Sunscreen

Directions
  • apply liberally and evenly 15 minutes before sun exposure 
  • reapply at least every 2 hours 
  • use a water-resistant sunscreen if swimming or sweating 
  • 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”  “Sun Protection Measures.



  • Children under 6 months of age: Ask a doctor
Other Information (Other information)

Protect the product in this container from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Coconut Alkanes, Glyceryl Stearate, Caramel, Glycerin, Silica, PEG-100 Stearate, Polyhydroxystearic Acid, Dimethicone, Glyceryl Stearate Citrate, Polymethylsilsesquioxane/Silica Crosspolymer, Potassium Cetyl Phosphate, Stearic Acid, Phenoxyethanol, Polyglyceryl-3 Stearate, Coco-Caprylate/Caprate, Sodium Stearoyl Glutamate, Hydrogenated Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysilicone-11, Squalane, Bisabolol, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Xanthan Gum, Citric Acid,Aloe Barbadensis Leaf Juice Powder, Ethylhexylglycerin, Panthenol, Lecithin, Polysorbate 60, Trisodium Ethylenediamine Disuccinate, 1,2-Hexanediol, Tocopherol, Ascorbyl Palmitate, Sorbitan Isostearate, Biosaccharide Gum-4, Helianthus Annuus (Sunflower) Seed Oil.

Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Package Labeling:

Active Ingredients (Active ingredients)

Zinc Oxide 22%

Questions Or Comments? (Questions or comments?)

Call toll free (833) 981-2335

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if rash occurs
Keep Out of Reach of Children. (Keep out of reach of children.)
  • If product is swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data


Raw Label Data

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