SPL v1
SPL
SPL Set ID 303e84e1-3bea-ea6f-e063-6294a90aeaa7
Route
TOPICAL
Published
Effective Date 2022-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (16 mg)
Inactive Ingredients
Propanediol Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Polysilicone-15 Trisodium Ethylenediamine Disuccinate Glycine Soja (soybean) Oil Polyglyceryl-3 Diisostearate Water Coconut Alkanes Stearyl Triethoxysilane Polymethylsilsesquioxane (11 Microns) Bisabolol Cistus Incanus Flowering Top .alpha.-tocopherol Acetate, Dl- Triethyl Citrate Phenylpropanol Caprylhydroxamic Acid Iron Oxides Cocoglycerides Oryza Sativa (rice) Starch Oryza Sativa (rice) Germ Oil Polyhydroxystearic Acid (2300 Mw) Zingiber Officinale (ginger) Root Oil Disteardimonium Hectorite Sodium Chloride Glycerin Sodium Citrate Dimethicone Peg/ppg-18/18 Dimethicone Coco-caprylate/caprate Caprylyl Methicone 1,2-hexanediol Butyloctyl Salicylate Isoamyl Laurate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-10

Description

Zonc Oxide 16%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zonc Oxide 16%

Uses

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

Warnings

For external use only

Directions

Apply Liberally 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. to 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses

Children under 6 months of age: Ask a doctor

Do Not Use

on damages or broken skin

Other Information

Protect this product from excessive heat or direct sun

Active Ingredients

Zonc Oxide 16%

Inactive Ingredients

Water, Isoamyl Laurate, Dimethicone, Polymethylsilsesquioxane/Silica Crosspolymer, Propanediol, Butyloctyl Salicylate, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-18/18 Dimethicone, Cocoglycerides, Coconut Alkanes, Sodium Chloride, Polyhydroxystearic Acid, Oryza Sativa (Rice) Germ Extract, Oryza Sativa (Rice) Extract, Bisabolol, Zingiber Officinale (Ginger) Root Extract, Cistus Incanus Flower/Leaf/Stem Extract, Coco-Caprylate/Caprate, Polysilicone-11, Caprylyl Methicone, Disteardimonium Hectorite, Tocopheryl Acetate, Triethyl Citrate, Tocopherol, Stearyl Triethoxysilane, Glycine Soja (Soybean) Oil, Polyglyceryl-3 Diisostearate, Phenylpropanol, 1,2-Hexanediol, Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Sodium Citrate, Iron Oxides

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

Lancer Mineral Sun Shield Universal Tint Broad Spectrum Spf 30 Sunscreen, 2.0 Fl Oz


Structured Label Content

Uses

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

Purpose

Sunscreen

Warnings

For external use only

Directions

Apply Liberally 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. to 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses

Children under 6 months of age: Ask a doctor

Do Not Use (Do not use)

on damages or broken skin

Other Information (Other information)

Protect this product from excessive heat or direct sun

Active Ingredients (Active ingredients)

Zonc Oxide 16%

Inactive Ingredients

Water, Isoamyl Laurate, Dimethicone, Polymethylsilsesquioxane/Silica Crosspolymer, Propanediol, Butyloctyl Salicylate, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-18/18 Dimethicone, Cocoglycerides, Coconut Alkanes, Sodium Chloride, Polyhydroxystearic Acid, Oryza Sativa (Rice) Germ Extract, Oryza Sativa (Rice) Extract, Bisabolol, Zingiber Officinale (Ginger) Root Extract, Cistus Incanus Flower/Leaf/Stem Extract, Coco-Caprylate/Caprate, Polysilicone-11, Caprylyl Methicone, Disteardimonium Hectorite, Tocopheryl Acetate, Triethyl Citrate, Tocopherol, Stearyl Triethoxysilane, Glycine Soja (Soybean) Oil, Polyglyceryl-3 Diisostearate, Phenylpropanol, 1,2-Hexanediol, Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Sodium Citrate, Iron Oxides

When Using This Product (When using this product)

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (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

Lancer Mineral Sun Shield Universal Tint Broad Spectrum Spf 30 Sunscreen, 2.0 Fl Oz (Lancer Mineral Sun Shield Universal Tint Broad Spectrum SPF-30 Sunscreen, 2.0 fl oz)


Advanced Ingredient Data


Raw Label Data

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