SPL v2
SPL
SPL Set ID 3aeb0f66-d613-9bc8-e063-6294a90a691d
Route
TOPICAL
Published
Effective Date 2025-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (19.5 g) Zinc Oxide (24 g)
Inactive Ingredients
Mica Lavandula Angustifolia (lavender) Oil Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Aluminum Hydroxide Lophatherum Gracile Leaf Potassium Sorbate Daucus Carota Sativa (carrot) Seed Oil Tocopherol Ci 77491 Sodium Benzoate Ci 77492 Dimethicone Triethoxycaprylylsilane Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-27

Description

TITANIUM DIOXIDE 19.5% ZINC OXIDE24%


Medication Information

Warnings and Precautions

For enemal use onyDo nd use on damaged or icken shnwmen using his poductkep ou oeyes Rise wth walerto remove slop use and ask adoco lrash occursKeep out d reachof thilien. producs

swallowed. get medical helpor contact a Potson Control Center rightaway

Indications and Usage

Apoly liberally i5 mnutes before sunexoosure.pants, hats andsunglasses. Children under 6months of age: ask a doctor

Reapph: Aler 80 minues oswinming or sneaing immetlaletater ionel dning Atleast eveny2hours.Sun precion leasures Spending ime in the sun increasesyour isk oifshincancer and eaty skinaging T

decrease this rsk requlanuse a sunsren uith a bradspecnum spf value of 15 or higtherAnd ohersun prolecion measureshclud ng imtime ihthe sun especdaly fom 10am.2am.

Dosage and Administration

Apoly liberally i5 mnutes before sunexoosure.pants, hats andsunglasses. Children under 6months of age: ask a doctor

Reapph: Aler 80 minues oswinming or sneaing immetlaletater ionel dning Atleast eveny2hours.Sun precion leasures Spending ime in the sun increasesyour isk oifshincancer and eaty skinaging T

decrease this rsk requlanuse a sunsren uith a bradspecnum spf value of 15 or higtherAnd ohersun prolecion measureshclud ng imtime ihthe sun especdaly fom 10am.2am.

Description

TITANIUM DIOXIDE 19.5% ZINC OXIDE24%

Section 50565-1

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

Section 50567-7

Helps prevent sunbum fused as directed with other sunprotection measures(see Directions)decreases the risk of skin cancer andeary skin aging caused by the sun

Section 51727-6

Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Aluminum hydroxide

Mica

Lophatherum Gracile Leaf

Dimethicone

Triethoxycaprylylsilane

Stearic Acid

Tocopherol

CI 77492

CI 77491

Sodium Benzoate

Potassium Sorbate

Daucus Carota Sativa (Carrot) Seed Oil

Lavandula Angustifolia (Lavender) Oil

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

TITANIUM DIOXIDE

19.5%

ZINC OXIDE24%

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

Apoly liberally i5 mnutes before sunexoosure.pants, hats andsunglasses. Children under 6months of age: ask a doctor

Reapph: Aler 80 minues oswinming or sneaing immetlaletater ionel dning Atleast eveny2hours.Sun precion leasures Spending ime in the sun increasesyour isk oifshincancer and eaty skinaging T

decrease this rsk requlanuse a sunsren uith a bradspecnum spf value of 15 or higtherAnd ohersun prolecion measureshclud ng imtime ihthe sun especdaly fom 10am.2am.

Dosage and Administration (34068-7)

Apoly liberally i5 mnutes before sunexoosure.pants, hats andsunglasses. Children under 6months of age: ask a doctor

Reapph: Aler 80 minues oswinming or sneaing immetlaletater ionel dning Atleast eveny2hours.Sun precion leasures Spending ime in the sun increasesyour isk oifshincancer and eaty skinaging T

decrease this rsk requlanuse a sunsren uith a bradspecnum spf value of 15 or higtherAnd ohersun prolecion measureshclud ng imtime ihthe sun especdaly fom 10am.2am.

Warnings and Precautions (34071-1)

For enemal use onyDo nd use on damaged or icken shnwmen using his poductkep ou oeyes Rise wth walerto remove slop use and ask adoco lrash occursKeep out d reachof thilien. producs

swallowed. get medical helpor contact a Potson Control Center rightaway

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

Helps prevent sunbum fused as directed with other sunprotection measures(see Directions)decreases the risk of skin cancer andeary skin aging caused by the sun

Section 51727-6 (51727-6)

Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Aluminum hydroxide

Mica

Lophatherum Gracile Leaf

Dimethicone

Triethoxycaprylylsilane

Stearic Acid

Tocopherol

CI 77492

CI 77491

Sodium Benzoate

Potassium Sorbate

Daucus Carota Sativa (Carrot) Seed Oil

Lavandula Angustifolia (Lavender) Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

TITANIUM DIOXIDE

19.5%

ZINC OXIDE24%

Section 60561-8 (60561-8)

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


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Raw Label Data

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