SPL v2
SPL
SPL Set ID 3a554118-b71d-a844-e063-6294a90a699f
Route
TOPICAL
Published
Effective Date 2025-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (240 mg) Titanium Dioxide (195 mg)
Inactive Ingredients
Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Potassium Sorbate Mica Ci 77491 Lavandula Angustifolia (lavender) Oil Triethoxycaprylylsilane Stearic Acid Tocopherol Lophatherum Gracile Leaf Aluminum Hydroxide Ci 77492 Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-20

Description

Titanium dioxide-19.5% Zinc oxide-24%


Medication Information

Warnings and Precautions

For external use only.Do not use on damaged or broken skinWhen using this product keep out ofeyes. Rinse with water to remove.Stop use and ask a doctor if rash occursKeep out of reach of children. lfproducts swallowed. get medical helpor contact a Poison Control Center rightaway.

Indications and Usage

Apply liberally 15 minutes before sunexposure.

Reapply: After 80 minutes ofswimming or sweating. immediatelyafter towel drying.At least every 2 hours.Sun Protection Measures.Spending time in the sun increasesyour risk of skin cancer and early skinaging. To decrease this risk, regularlyuse a sunscreen with a broadspectrum SPF value of 15 or higher.And other sun protection measuresincluding: Limit time in the sun,especially from 10am-2pm. wearlong-sleeved shirts, pants, hats andsunglasses. Children under 6months of age: ask a doctor

Dosage and Administration

Apply liberally 15 minutes before sunexposure.

Reapply: After 80 minutes ofswimming or sweating. immediatelyafter towel drying.At least every 2 hours.Sun Protection Measures.Spending time in the sun increasesyour risk of skin cancer and early skinaging. To decrease this risk, regularlyuse a sunscreen with a broadspectrum SPF value of 15 or higher.And other sun protection measuresincluding: Limit time in the sun,especially from 10am-2pm. wearlong-sleeved shirts, pants, hats andsunglasses. Children under 6months of age: ask a doctor

Description

Titanium dioxide-19.5% Zinc oxide-24%

Section 50565-1

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

Section 50567-7

Helps prevent sunburn.If used as directed with other sunprotection measures(see Directions)decreases the risk of skin cancer andearly skin aging caused by the sun.

Section 51727-6

Vinyl Dimethicone/MethiconeSilsesquioxane Crosspolymer.

Aluminum hydroxide.

LavandulaAngustifolia (Lavender) Oil,

Mica.

Lophatherum Gracile Leaf Power,

Dimethicone,

Triethoxycoprylylsilane

.Stearic Acid,

Tocopherol(Vitamin E),

C1 77492,

C1 77491

Sodium Benzoate

,Potassium Sorbate

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium dioxide-19.5%

Zinc oxide-24%

Section 60561-8

Protect this product in this container from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Apply liberally 15 minutes before sunexposure.

Reapply: After 80 minutes ofswimming or sweating. immediatelyafter towel drying.At least every 2 hours.Sun Protection Measures.Spending time in the sun increasesyour risk of skin cancer and early skinaging. To decrease this risk, regularlyuse a sunscreen with a broadspectrum SPF value of 15 or higher.And other sun protection measuresincluding: Limit time in the sun,especially from 10am-2pm. wearlong-sleeved shirts, pants, hats andsunglasses. Children under 6months of age: ask a doctor

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sunexposure.

Reapply: After 80 minutes ofswimming or sweating. immediatelyafter towel drying.At least every 2 hours.Sun Protection Measures.Spending time in the sun increasesyour risk of skin cancer and early skinaging. To decrease this risk, regularlyuse a sunscreen with a broadspectrum SPF value of 15 or higher.And other sun protection measuresincluding: Limit time in the sun,especially from 10am-2pm. wearlong-sleeved shirts, pants, hats andsunglasses. Children under 6months of age: ask a doctor

Warnings and Precautions (34071-1)

For external use only.Do not use on damaged or broken skinWhen using this product keep out ofeyes. Rinse with water to remove.Stop use and ask a doctor if rash occursKeep out of reach of children. lfproducts swallowed. get medical helpor contact a Poison Control Center rightaway.

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 50567-7 (50567-7)

Helps prevent sunburn.If used as directed with other sunprotection measures(see Directions)decreases the risk of skin cancer andearly skin aging caused by the sun.

Section 51727-6 (51727-6)

Vinyl Dimethicone/MethiconeSilsesquioxane Crosspolymer.

Aluminum hydroxide.

LavandulaAngustifolia (Lavender) Oil,

Mica.

Lophatherum Gracile Leaf Power,

Dimethicone,

Triethoxycoprylylsilane

.Stearic Acid,

Tocopherol(Vitamin E),

C1 77492,

C1 77491

Sodium Benzoate

,Potassium Sorbate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium dioxide-19.5%

Zinc oxide-24%

Section 60561-8 (60561-8)

Protect this product in this container from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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