83447-010

83447-010
SPL v2
SPL
SPL Set ID 225faeec-4f96-e082-e063-6394a90a9a31
Route
TOPICAL
Published
Effective Date 2024-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24 g)
Inactive Ingredients
Centella Asiatica Triterpenoids Coconut Oil Polyglyceryl-4 Isostearate Lemon Cetyl Dimethicone 25 Tocopherol Hyaluronate Sodium Potassium Sorbate Water Aloe Vera Leaf Medium-chain Triglycerides Sorbitan Monostearate Hexyl Laurate Ceramide Ns Jojoba Oil Watermelon Niacinamide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-18

Description

Zinc Oxide 24%


Medication Information

Description

Zinc Oxide 24%

Uses

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 24%

Warnings

① For external use only.

② When using this product keep out of eyes.

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

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 value 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 n mornths: ask a doctor.

Inactive Ingredients

aqua, aloe barbadensis leaf juice, caprylic/ capric triglycerides, sorbitan stearate, polyglyceryl-4 isostearate, hexyl laurate, cetyl

dimethicone, helianthus annuus (sunflower) seed oil, simmondsia chinensis (jojoba) seed oil, citrullus lanatus

(watermelon) fruit extract, rubus chamaemorus (cloudberry) fruit extract, niacinamide, centella asiatica extract, ceramide NP,

tocopherol (vitamin e), citrus limon (lemon) fruit extract, sodium hyaluronate, watermelon essential oil, potassium sorbate.




Structured Label Content

Uses

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 24%

Warnings

① For external use only.

② When using this product keep out of eyes.

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)

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 value 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 n mornths: ask a doctor.

Inactive Ingredients

aqua, aloe barbadensis leaf juice, caprylic/ capric triglycerides, sorbitan stearate, polyglyceryl-4 isostearate, hexyl laurate, cetyl

dimethicone, helianthus annuus (sunflower) seed oil, simmondsia chinensis (jojoba) seed oil, citrullus lanatus

(watermelon) fruit extract, rubus chamaemorus (cloudberry) fruit extract, niacinamide, centella asiatica extract, ceramide NP,

tocopherol (vitamin e), citrus limon (lemon) fruit extract, sodium hyaluronate, watermelon essential oil, potassium sorbate.




Advanced Ingredient Data


Raw Label Data

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