SPL v2
SPL
SPL Set ID 3ee96538-06e8-75b1-e063-6394a90a5285
Route
CUTANEOUS
Published
Effective Date 2025-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (25 g)
Inactive Ingredients
Glycerin Acrylates/vinyl Isodecanoate Crosspolymer (10000 Mpa.s Neutralized At 0.5%) 1,2-hexanediol Decyl Glucoside Hydrogen Dimethicone (20 Cst) Hydroxyacetophenone Simmondsia Chinensis (jojoba) Seed Oil Aluminum Starch Octenylsuccinate Ethylhexyl Methoxycinnamate Ascorbic Acid Dimethicone Glutathione Methylene Bis-benzotriazolyl Tetramethylbutylphenol Xanthan Gum Water Raphanus Sativus Butylene Glycol Beeswax Calcium Bis-ethylhexyloxyphenol Methoxyphenyl Triazine Bht Butyrospermum Parkii (shea) Butter Tocopherol Hydrogenated Soybean Lecithin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-16

Description

Non-Nano Zinc Oxide 25%


Medication Information

Warnings and Precautions

For external use only.Do not use on damaged or broken skin.When using this product keep out of eyes. Rinse with waterto remove.Stop use and ask a doctor if rash occurs.Keep out of reach of children. lf product is swallowed, getmedical help or contact a Poison Control Center right away.

Indications and Usage

helps prevent sunburn.

if used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skinaging caused by the sun

Dosage and Administration

apply liberally 15 minutes before sun exposure

reapply: * after 80 minutes of swimming or sweatingimmediately after towel drying* at least every 2 hours

Description

Non-Nano Zinc Oxide 25%

Section 43685-7

For external use only.Do not use on damaged or broken skin.When using this product keep out of eyes. Rinse with waterto remove.

Stop use and ask a doctor if rash occurs.Keep out of reach of children. lf product is swallowed, getmedical help or contact a Poison Control Center right away.

Section 50565-1

Keep out of reach of children. lf product is swallowed, getmedical help or contact a Poison Control Center right away.

Section 51727-6

Water,Ethyhexy Methoxycinnamate,Butyene Glycol,ZincOxideDimethicone,Bis-ethyhexyloxyphenol Methoxypheny'TriazineMethyene Bis-benzotriazoly Tetramethybutyphenol,OctocryleneTriceteareth-4 Phosphate,Glycerin,Calcium StarchOctenylsuccinateTocopherol,Simmondsia Chinensis (Jojoba)Seed Oil,RaphanusSativus,Beeswax,Butyrospermum Parkii(Shea) Butter,l ydrogenatedLecithin,Ascorbic Acid,Hydroxyacetophenone, 1,2-hexanediolDecy Glucoside,Acrylates/vinyIsodecanoate Crosspolymer,Hydrogen Dimethicone,XanthanGum,Bht

Section 51945-4

Section 55105-1

helps prevent sunburn.if used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skinaging caused by the sun

Section 55106-9

Non-Nano Zinc Oxide 25%

Section 59845-8

shake well before use,apply liberally 15 minutes before sun exposure,reapply:* after 80 minutes of swimming or sweating*immediately after towel drying* at least every 2 hours,children after 6 months of age: ask a doctor,Sun Protection Measures,Spendina time in the sun increases

your risk of skin cancer and eary skin aging, To decrease this riskregularly use a sunscreen with a broad spectrum SPF of 15 ohigher and other sun protection measures including.

limit time in the sun,especially from10am-2pm

wear long-sleeve shirts, pants, hats, and sunglasses


Structured Label Content

Indications and Usage (34067-9)

helps prevent sunburn.

if used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skinaging caused by the sun

Dosage and Administration (34068-7)

apply liberally 15 minutes before sun exposure

reapply: * after 80 minutes of swimming or sweatingimmediately after towel drying* at least every 2 hours

Warnings and Precautions (34071-1)

For external use only.Do not use on damaged or broken skin.When using this product keep out of eyes. Rinse with waterto remove.Stop use and ask a doctor if rash occurs.Keep out of reach of children. lf product is swallowed, getmedical help or contact a Poison Control Center right away.

Section 43685-7 (43685-7)

For external use only.Do not use on damaged or broken skin.When using this product keep out of eyes. Rinse with waterto remove.

Stop use and ask a doctor if rash occurs.Keep out of reach of children. lf product is swallowed, getmedical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children. lf product is swallowed, getmedical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Water,Ethyhexy Methoxycinnamate,Butyene Glycol,ZincOxideDimethicone,Bis-ethyhexyloxyphenol Methoxypheny'TriazineMethyene Bis-benzotriazoly Tetramethybutyphenol,OctocryleneTriceteareth-4 Phosphate,Glycerin,Calcium StarchOctenylsuccinateTocopherol,Simmondsia Chinensis (Jojoba)Seed Oil,RaphanusSativus,Beeswax,Butyrospermum Parkii(Shea) Butter,l ydrogenatedLecithin,Ascorbic Acid,Hydroxyacetophenone, 1,2-hexanediolDecy Glucoside,Acrylates/vinyIsodecanoate Crosspolymer,Hydrogen Dimethicone,XanthanGum,Bht

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

helps prevent sunburn.if used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skinaging caused by the sun

Section 55106-9 (55106-9)

Non-Nano Zinc Oxide 25%

Section 59845-8 (59845-8)

shake well before use,apply liberally 15 minutes before sun exposure,reapply:* after 80 minutes of swimming or sweating*immediately after towel drying* at least every 2 hours,children after 6 months of age: ask a doctor,Sun Protection Measures,Spendina time in the sun increases

your risk of skin cancer and eary skin aging, To decrease this riskregularly use a sunscreen with a broad spectrum SPF of 15 ohigher and other sun protection measures including.

limit time in the sun,especially from10am-2pm

wear long-sleeve shirts, pants, hats, and sunglasses


Advanced Ingredient Data


Raw Label Data

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