Drug Facts

Active Ingredients

Titanium Dioxide 3.64%

Zinc Oxide 2.98%

Purposes

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

ir rash occurs

Keep out of reach of children.

Directions

Apply generously 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating
Children under 6 months of age: Ask a doctor

Other Information

protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water, Diemthicone, Caprylic/Capric Triglyceride, Glycerin, Aloe Barbadensis Leaf Juice, Niacinamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Fragrance, Rubus Idaeus(Raspberry) Seed Extract, Chondrus Crispus Extract, Oryza Sativa (Rice) Extract, Spirulina Platensis Extract, Spirulina Maxima Extract, Panax Ginseng Root Extract, Alumina, Hyaluronic Acid, Leuconostoc/Radish Root Ferment Filtrate, Sodium Potassium Aluminum Silicate, Polyhydroxystearic Acid, Stearic Acid, Triethoxycaprylylsilane, Superoxide Dismutase, Soybean Peroxidase, Hydrogenated Lecithin, Hydrogenated Phosphatidylcholine, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Aminomethyl Propanol, Titanium Dioxide, Xanthan Gum, Sodium Carbomer, Citric Acid

Package Labeling:

Outer Package4 Inner Package4

SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14268-120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	364 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	298 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
NIACINAMIDE (UNII: 25X51I8RD4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
RICE GERM (UNII: 7N2B70SFEZ)
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)
ASIAN GINSENG (UNII: CUQ3A77YXI)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYALURONIC ACID (UNII: S270N0TRQY)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14268-120-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	03/01/2023

Labeler - ENGLEWOOD LAB, INC. (172198223)