Mineral Sunscreen Spray Spf50

Mineral Sunscreen Spray Spf50
SPL v3
SPL
SPL Set ID 01cc554b-9241-d891-e063-6394a90a8450
Route
TOPICAL
Published
Effective Date 2025-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (160 mg) Titanium Dioxide (34 mg)
Inactive Ingredients
Water Isononyl Isononanoate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Isocetyl Stearoyl Stearate C18-c21 Alkane Dicaprylyl Carbonate Methyl Dihydroabietate Sodium Stearoyl Glutamate Silicon Dioxide Aluminum Oxide Citric Acid Monohydrate Microcrystalline Cellulose Carboxymethylcellulose Sodium Levomenol Polyhydroxystearic Acid Stearate Sodium Gluconate Tocopherol Glycerin Caprylhydroxamic Acid Aloe Vera Leaf Cetostearyl Alcohol Caprylyl Glycol Butyloctyl Salicylate Propanediol Coco Glucoside Banana

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-13

Description

Titanium Dioxide 3.4% Zinc Oxide 16%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 3.4% Zinc Oxide 16%

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 51945-4

Warnings

For external use only

Flammable: Do not use near heat, flame, or while smoking

Directions
  • Shake well before use
  • Apply liberally and spread evenly by hand 15 minutes before sun exposure
  • Hold 4 to 6 inches away from body when spraying
  • For children under 6 months of age, ask a doctor
  • Do not spray directly on face
  • Spray on hand and apply to face. Use in well-ventilated areas. Do not apply in wind conditions.
  • Reapply: • after 80 minutes of swimming or sweating • immediately after towel use • at least every 2 hours
  • Sun Protection Measures: Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10a.m. - 2p.m. • Wear long-sleeved shirts, pants, hats and sunglasses
Do Not Use On

broken or damaged skin

Other Information
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
Active Ingredients

Titanium Dioxide 3.4%

Zinc Oxide 16%

Inactive Ingredients

Water (Aqua), Butyloctyl Salicylate, Isononyl Isnonanoate, Dicaprylyl Carbonate, Methyl Dihydroabietate, Propanediol, Isocetyl Stearoyl Stearate, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Polyester-8, C18-21 Alkane, Silica, Alumina, Tocopherol, Bisabolol, Polyhydroxystearic Acid, Coco-Glucoside, Glycerin, Caprylyl Glycol, Caprylhydroxamic Acid, Musa Sapientum (Banana) Fruit Extract, Sodium Gluconate, Citric Acid, Aloe Barbadensis Leaf Juice, Bentonite, Microcrystalline Cellulose, Cellulose Gum

When Using This Product

Keep away from face and avoid breathing it. Keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away


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 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Flammable: Do not use near heat, flame, or while smoking

Directions
  • Shake well before use
  • Apply liberally and spread evenly by hand 15 minutes before sun exposure
  • Hold 4 to 6 inches away from body when spraying
  • For children under 6 months of age, ask a doctor
  • Do not spray directly on face
  • Spray on hand and apply to face. Use in well-ventilated areas. Do not apply in wind conditions.
  • Reapply: • after 80 minutes of swimming or sweating • immediately after towel use • at least every 2 hours
  • Sun Protection Measures: Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10a.m. - 2p.m. • Wear long-sleeved shirts, pants, hats and sunglasses
Do Not Use On (Do not use on)

broken or damaged skin

Other Information
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
Active Ingredients

Titanium Dioxide 3.4%

Zinc Oxide 16%

Inactive Ingredients

Water (Aqua), Butyloctyl Salicylate, Isononyl Isnonanoate, Dicaprylyl Carbonate, Methyl Dihydroabietate, Propanediol, Isocetyl Stearoyl Stearate, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Polyester-8, C18-21 Alkane, Silica, Alumina, Tocopherol, Bisabolol, Polyhydroxystearic Acid, Coco-Glucoside, Glycerin, Caprylyl Glycol, Caprylhydroxamic Acid, Musa Sapientum (Banana) Fruit Extract, Sodium Gluconate, Citric Acid, Aloe Barbadensis Leaf Juice, Bentonite, Microcrystalline Cellulose, Cellulose Gum

When Using This Product (When using this product)

Keep away from face and avoid breathing it. Keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F.

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 swallowed, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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