400c67aa-55a6-67ea-e063-6294a90a0213

SPL v1
SPL
SPL Set ID 400c67aa-55a6-67ea-e063-6294a90a0213
Route
topical
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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

Other Information



. protect product from excessive heat and direct sun

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Glycerin,Caprylic/CapricTriglyceride,

Polyglyceryl-6 Polyricinoleate,Coconut Alkanes,C13-15Alkane,Isododecane,Silica,Triheptanoin,

Polyhydroxystearic Acid,Coco-Caprylate/Caprate,Polyglyceryl-10 Dioleate,Melia Azadirachta

Extract, Glyceryl Caprylate, Fragrance, Sodium Chloride, Squalane, Hydrogenated

Phosphatidylcholine, Disteardimonium Hectorite, Saccharomyces Ferment, Propylene

Carbonate, Dilinoleic Acid/Butanediol Copolymer, Caprylhydroxamic Acid, Tocopheryl

Acetate, Moringa Oleifera Seed Oil, Lauroyl Lysine, Terminalia Ferdinandiana Fruit Extract,

Castor Oil/IPDI Copolymer, Fragaria Ananassa (Strawberry) Fruit Extract.

Description

Zinc Oxide 24.1%

Section 51945-4

Section 55105-1

Do Not Use

Do not use on damaged or broken skin.

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


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

Other Information (Other information)



. protect product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, C12-15 Alkyl Benzoate, Glycerin,Caprylic/CapricTriglyceride,

Polyglyceryl-6 Polyricinoleate,Coconut Alkanes,C13-15Alkane,Isododecane,Silica,Triheptanoin,

Polyhydroxystearic Acid,Coco-Caprylate/Caprate,Polyglyceryl-10 Dioleate,Melia Azadirachta

Extract, Glyceryl Caprylate, Fragrance, Sodium Chloride, Squalane, Hydrogenated

Phosphatidylcholine, Disteardimonium Hectorite, Saccharomyces Ferment, Propylene

Carbonate, Dilinoleic Acid/Butanediol Copolymer, Caprylhydroxamic Acid, Tocopheryl

Acetate, Moringa Oleifera Seed Oil, Lauroyl Lysine, Terminalia Ferdinandiana Fruit Extract,

Castor Oil/IPDI Copolymer, Fragaria Ananassa (Strawberry) Fruit Extract.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Do Not Use (Do not use)

Do not use on damaged or broken skin.

Keep Out of Reach of Children. (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


Advanced Ingredient Data


Raw Label Data

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