drug facts

drug facts
SPL v1
SPL
SPL Set ID 7415511e-1ecf-4646-b64b-267fbf7d116b
Route
topical
Published
Effective Date 2016-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (3.2 g) zinc oxide (4 g)
Inactive Ingredients
water medium-chain triglycerides isohexadecane butyloctyl salicylate sodium chloride ethylhexyl methoxycrylene dimethicone phenoxyethanol caprylyl glycol polyethylene glycol 400 aluminum oxide glycerin sodium citrate, unspecified form .alpha.-tocopherol acetate aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-06-02

Purpose

Sunscreen

Description

Titanium Dioxide  3.2%, Zinc Oxide 4.0%


Medication Information

Warnings

For external use only

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

Purpose

Sunscreen

Directions


  • apply liberally 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 skin aging.  To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Description

Titanium Dioxide  3.2%, Zinc Oxide 4.0%

Do Not Use

on damaged or broken skin

Active Ingredients

Titanium Dioxide  3.2%, Zinc Oxide 4.0%

Questions Or Comments?

Call 1-800-697-9868 Mon-Fri

Principle Display Label

NDC:  41250-922-57

meijer

tear free

kids

Sunscreen lotion

pediatrician tested

UVA/UVB protection

50

Broad Spectrum

SPF 50

Water Resistant

(80 minutes)

1 FL. OZ. (295 mL)

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.

  • May stain some fabrics

Structured Label Content

Warnings

For external use only

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

Purpose

Sunscreen

Directions


  • apply liberally 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 skin aging.  To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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

Other Information (Other information)

protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, Isohexadecane, Butyloctyl Salicylate, Octyldodecyl Citrate Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Sodium Chloride, Ethylhexyl Methoxycrylene, Dimethicone, Phenoxyethanol, Caprylyl Glycol, PEG-8, Alumina, Glycerin, Sodium Citrate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Titanium Dioxide  3.2%, Zinc Oxide 4.0%

Questions Or Comments? (Questions or comments?)

Call 1-800-697-9868 Mon-Fri

Principle Display Label

NDC:  41250-922-57

meijer

tear free

kids

Sunscreen lotion

pediatrician tested

UVA/UVB protection

50

Broad Spectrum

SPF 50

Water Resistant

(80 minutes)

1 FL. OZ. (295 mL)

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.

  • May stain some fabrics

Advanced Ingredient Data


Raw Label Data

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