Drug Facts

Active ingredients

Titanium Dioxide 10%

Zinc Oxide 5%

Purpose

Sunscreen

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

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.

Directions

For sunscreen use:

apply liberally and evenly 15 minutes before sun exposure
apply to all skin exposed to the sun
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
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 the product in this container from excessive heat and direct sun

Inactive ingredients

Water, Human Umbilical Mesenchymal Stem Cell Exosomes, Oat (Avena sativa) Extract, Stearic Acid, Sorbitan Stearate, Glycerin, Iron Oxide, Hydroxyacetophenone, Fragrance

Package Labeling:

Label0

SUNSCREEN COLOR BROAD SPECTRUM SPF 50
titanium dioxide, zinc oxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83802-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	100 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
OAT (UNII: Z6J799EAJK)
STEARIC ACID (UNII: 4ELV7Z65AP)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83802-001-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	12/01/2023

Labeler - CryoGen, LLC (127842726)

Sunscreen Gel Color Broad spectrum SPF 50+