83447-008

83447-008
SPL v3
SPL
SPL Set ID 1dfa80bd-495a-18fb-e063-6394a90a4d0d
Route
TOPICAL
Published
Effective Date 2024-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3 g) Zinc Oxide (12 g)
Inactive Ingredients
Water Glycerin Butyloctyl Salicylate Hyaluronate Sodium Dimethicone Glyceryl Monostearate Ethylhexylglycerin Peg-100 Stearate Xanthan Gum Phosphatidylcholine, Soybean Peg/ppg-17/6 Copolymer Pregnenolone Panthenol Cetyl Alcohol Niacinamide .alpha.-bisabolol, (+)- Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-24

Description

Zinc Oxide 12% Titanium Dioxide 3%


Medication Information

Description

Zinc Oxide 12% Titanium Dioxide 3%

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 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not use on damaged or broken skin.

Section 51945-4

Section 55105-1

sunscreen

Section 55106-9



Zinc Oxide 12%

Titanium Dioxide 3%

Warnings

Warnings:

①For external use only. ②Do not use on damaged or broken skin. ③When using this product keep out of eyes. Rinse with water to remove. ④Stop use and ask a doctor if rash occurs. ⑤Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. ⑥ May stain some fabrics.



Directions

Directions

apply liberally 15 minutes before sun exposure.●reapply after 40 minutes of swimming or sweating●immediately

after towel drying ●at least every 2 hours



Other Information

protect the product in this container from excessive heat and direct sun.



Inactive Ingredients

Water (Aqua)」Glycerin, Butyloctyl Salicylate, Dimethicone PEG I PPG-17/6 Copolymer, Glyceryl Stearate and

PEG-100 Stearate, Styrene/Acrylates Copolymer, Cetyl Alcohol, Niacinamide, Bisabolol, Sodium Hyaluronate,

Carbomer, Vitamin E, Lecithin, Panthenol, Xanthan Gum, Ethylhexylglycerin, Fragrance




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 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

sunscreen

Section 55106-9 (55106-9)



Zinc Oxide 12%

Titanium Dioxide 3%

Warnings

Warnings:

①For external use only. ②Do not use on damaged or broken skin. ③When using this product keep out of eyes. Rinse with water to remove. ④Stop use and ask a doctor if rash occurs. ⑤Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. ⑥ May stain some fabrics.



Directions

Directions

apply liberally 15 minutes before sun exposure.●reapply after 40 minutes of swimming or sweating●immediately

after towel drying ●at least every 2 hours



Other Information (Other information)

protect the product in this container from excessive heat and direct sun.



Inactive Ingredients

Water (Aqua)」Glycerin, Butyloctyl Salicylate, Dimethicone PEG I PPG-17/6 Copolymer, Glyceryl Stearate and

PEG-100 Stearate, Styrene/Acrylates Copolymer, Cetyl Alcohol, Niacinamide, Bisabolol, Sodium Hyaluronate,

Carbomer, Vitamin E, Lecithin, Panthenol, Xanthan Gum, Ethylhexylglycerin, Fragrance




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)