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

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.



Active Ingredient



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

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



Description

Zinc Oxide 12% Titanium Dioxide 3%

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


Structured Label Content

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.



Active Ingredient (55106-9)



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

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



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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)