40945805-6f2e-74a1-e063-6394a90a04a3

SPL v1
SPL
SPL Set ID 40945805-6f2e-74a1-e063-6394a90a04a3
Route
topical
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (241 mg)
Inactive Ingredients
coco-caprylate/caprate triheptanoin sodium chloride c13-15 alkane glycerin isododecane squalane polyglyceryl-6 polyricinoleate polyglyceryl-10 dioleate caprylhydroxamic acid dilinoleic acid/butanediol copolymer castor oil/ipdi copolymer glyceryl caprylate polyhydroxystearic acid (2300 mw) propylene carbonate water c12-15 alkyl benzoate coconut alkanes caprylic/capric triglyceride silica disteardimonium hectorite lauroyl lysine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-01

Description

Zinc Oxide 24.1%


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use on damaged or broken skin.

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.

Active Ingredient

Zinc Oxide 24.1%

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

Directions

Directions

. apply liberally and evenly 15 minutes before sun exposure

reapply:

. after 40 minutes of swimming or sweating

. at least every 2 hours

. children under 6 months of age: Ask a doctor

. 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-sleeved shirts, pants, hats, and sunglasses

Description

Zinc Oxide 24.1%

Section 44425-7

. protect product from excessive heat and direct sun

Section 50565-1

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

Section 50570-1

Do not use on damaged or broken skin.

Section 51727-6

Other Ingredients:

Water (Aqua)

C12-15 Alkyl Benzoate

Caprylic/Capric Triglyceride

C13-15 Alkane

Glycerin

Polyglyceryl-6 Polyricinoleate

Coconut Alkanes

Silica

Isododecane

Triheptanoin

Sodium Chloride

Squalane (Olive derived)

Fragrance

Terminalia Ferdinandiana Fruit Extract

Vaccinium Myrtillus (Blueberry) Fruit Extract

Coco-Caprylate/Caprate

Polyglyceryl-10 Dioleate

Disteardimonium Hectorite

Hydrogenated Phosphatidylcholine

Tocopheryl Acetate (Vitamin E)

Caprylhydroxamic Acid

Dilinoleic Acid/Butanediol Copolymer

Castor Oil/IPDI Copolymer

Glyceryl Caprylate

Polyhydroxystearic Acid

Genipa Aericana Fruit Extract

Propylene Carbonate

Saccharomyces Ferment

Lauroyl Lysine

Section 51945-4

Section 55105-1


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use on damaged or broken skin.

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.

Active Ingredient (55106-9)

Zinc Oxide 24.1%

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

Directions

Directions

. apply liberally and evenly 15 minutes before sun exposure

reapply:

. after 40 minutes of swimming or sweating

. at least every 2 hours

. children under 6 months of age: Ask a doctor

. 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-sleeved shirts, pants, hats, and sunglasses

Section 44425-7 (44425-7)

. protect product from excessive heat and direct sun

Section 50565-1 (50565-1)

Keep out of reach of children. If 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 51727-6 (51727-6)

Other Ingredients:

Water (Aqua)

C12-15 Alkyl Benzoate

Caprylic/Capric Triglyceride

C13-15 Alkane

Glycerin

Polyglyceryl-6 Polyricinoleate

Coconut Alkanes

Silica

Isododecane

Triheptanoin

Sodium Chloride

Squalane (Olive derived)

Fragrance

Terminalia Ferdinandiana Fruit Extract

Vaccinium Myrtillus (Blueberry) Fruit Extract

Coco-Caprylate/Caprate

Polyglyceryl-10 Dioleate

Disteardimonium Hectorite

Hydrogenated Phosphatidylcholine

Tocopheryl Acetate (Vitamin E)

Caprylhydroxamic Acid

Dilinoleic Acid/Butanediol Copolymer

Castor Oil/IPDI Copolymer

Glyceryl Caprylate

Polyhydroxystearic Acid

Genipa Aericana Fruit Extract

Propylene Carbonate

Saccharomyces Ferment

Lauroyl Lysine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)


Advanced Ingredient Data


Raw Label Data

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