Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID be563db3-2353-1cf8-e053-2995a90af6c4
Route
TOPICAL
Published
Effective Date 2020-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Adenosine (0.04 g) Niacinamide (2 g) Titanium Dioxide (7 g) Zinc Cation (13 g)
Inactive Ingredients
Water Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-01

Description

Zinc Oxide, Titanium Dioxide, Niacinamide, Adenosine


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 or redness occurs

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

Other information

*do not store this product under the direct sun light or the excessive heat

*may stain some fabrics or surfaces

Indications and Usage

Directions

*Apply liberally 15 minutes before sun exposure

*Apply all skin will be exposed to the sun

*Reapply *after 80 minutes of swimming or sweating *immediately after towel drying

*at least every 2 hours

*children under the age of 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 sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: *limit time in the sun, especially from 10 AM to 2 PM *wear long-sleeve shirts, pants, hats, and sunglasses

Dosage and Administration

external use only

Description

Zinc Oxide, Titanium Dioxide, Niacinamide, Adenosine

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water, Propylheptyl Caprylate, Acrylates Copolymer, Butyloctyl Salicylate, Dicaprylyl Ether, Butylene Glycol, Dicaprylate/Dicaprate, Disiloxane, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Silica, Dimethicone, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexylglycerin, Disteardimonium Hectorite, Magnesium Sulfate, 1,2-Hexanediol, Disodium EDTA, Fragrance, Citral, Citronellol, Limonene, Hexyl Cinnamal, Hydroxycitronellal, Linalool, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde,

Section 51945-4

Section 55105-1

Helps prevent sunburn*if used as directed with other sun protection measures (see under Directions), decreases the risk of skin cancer and early skin aging by the sun

Section 55106-9

Zinc Oxide, Titanium Dioxide, Niacinamide, Adenosine


Structured Label Content

Indications and Usage (34067-9)

Directions

*Apply liberally 15 minutes before sun exposure

*Apply all skin will be exposed to the sun

*Reapply *after 80 minutes of swimming or sweating *immediately after towel drying

*at least every 2 hours

*children under the age of 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 sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: *limit time in the sun, especially from 10 AM to 2 PM *wear long-sleeve shirts, pants, hats, and sunglasses

Dosage and Administration (34068-7)

external use only

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 or redness occurs

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

Other information

*do not store this product under the direct sun light or the excessive heat

*may stain some fabrics or surfaces

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water, Propylheptyl Caprylate, Acrylates Copolymer, Butyloctyl Salicylate, Dicaprylyl Ether, Butylene Glycol, Dicaprylate/Dicaprate, Disiloxane, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Silica, Dimethicone, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexylglycerin, Disteardimonium Hectorite, Magnesium Sulfate, 1,2-Hexanediol, Disodium EDTA, Fragrance, Citral, Citronellol, Limonene, Hexyl Cinnamal, Hydroxycitronellal, Linalool, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde,

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps prevent sunburn*if used as directed with other sun protection measures (see under Directions), decreases the risk of skin cancer and early skin aging by the sun

Section 55106-9 (55106-9)

Zinc Oxide, Titanium Dioxide, Niacinamide, Adenosine


Advanced Ingredient Data


Raw Label Data

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