Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID decfb4bd-c7aa-46eb-ac08-eee56ef4390f
Route
TOPICAL
Published
Effective Date 2012-10-04
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3.1 g) Zinc Oxide (4 g)
Inactive Ingredients
Water Medium-chain Triglycerides Isohexadecane Butyloctyl Salicylate Cetyl Peg/ppg-10/1 Dimethicone (hlb 1.5) Sodium Chloride Ethylhexyl Methoxycrylene Dimethicone Caprylyl Glycol Polyethylene Glycol 400 Aluminum Oxide Glycerin Sodium Citrate .alpha.-tocopherol Acetate Aloe Vera Leaf Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-10-03

Description

Titanium Dioxide 3.1% Zinc Oxide 4.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 3.1% Zinc Oxide 4.0%

Uses
  • helps prevent sunburn
  • if used as directed wiht other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings
  • For external use only
  • Do not use on damaged or broken skin
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, regulatory 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.-2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor
Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients

Titanium Dioxide 3.1%

Zinc Oxide 4.0%

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

Banana Boat

Baby

Tear Free Sting Free

UVA/UVB Protection

Sunscreen Lotion

50

Broad Spectrum SPF 50

Pediatrician Tested

Proven to be Gentle

Water Resistant (80 minutes)

Recommended Skin Cancer Foundation

Active

Recommended as an effective UV sunscreen

Swim Splash Play

8 FL. OZ. (236 mL)

Bonus 25% More

Banana Boat

Baby

Tear Free Sting Free

UVA/UVB Protection

Sunscreen Lotion

50

Broad Spectrum SPF 50

Pediatrician Tested

Proven to be Gentle

Water Resistant (80 minutes)

Recommended Skin Cancer Foundation

Active

Recommended as an effective UV sunscreen

Swim Splash Play

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

May stain some fabrics.


Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed wiht other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Warnings
  • For external use only
  • Do not use on damaged or broken skin
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, regulatory 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.-2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor
Other Information (Other information)
  • protect this product from excessive heat and direct sun
Active Ingredients

Titanium Dioxide 3.1%

Zinc Oxide 4.0%

Questions Or Comments? (Questions or Comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

Banana Boat

Baby

Tear Free Sting Free

UVA/UVB Protection

Sunscreen Lotion

50

Broad Spectrum SPF 50

Pediatrician Tested

Proven to be Gentle

Water Resistant (80 minutes)

Recommended Skin Cancer Foundation

Active

Recommended as an effective UV sunscreen

Swim Splash Play

8 FL. OZ. (236 mL)

Bonus 25% More

Banana Boat

Baby

Tear Free Sting Free

UVA/UVB Protection

Sunscreen Lotion

50

Broad Spectrum SPF 50

Pediatrician Tested

Proven to be Gentle

Water Resistant (80 minutes)

Recommended Skin Cancer Foundation

Active

Recommended as an effective UV sunscreen

Swim Splash Play

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

May stain some fabrics.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)