Drug Facts

Active Ingredients

Zinc Oxide (17.5%)

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:

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours 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 value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. – 2p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
use water resistant sunscreen if swimming or sweating
Children under 6 months of age: Ask a doctor.

Inactive Ingredients:

Water (Aqua), Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Oil, Cocos Nucifera (Coconut) Oil, Sorbitan Stearate, Polyglyceryl-10 Laurate, Glycerin*, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, Magnesium Sulfate, Gluconolactone, Triethoxycaprylylsilane, Sodium Benzoate, Santalum Album (Sandalwood) Oil, Glycerin, Xanthan Gum, Simmondsia Chinensis (Jojoba) Seed Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Virgin Coconut) Oil*, Calcium Gluconate, Sodium Hyaluronate, Palmitoyl Tetrapeptide-7, Palmitoyl Hexapeptide-12. *Certified Organic. May Contain: Iron Oxide CI 77492, Iron Oxide CI 77491, Iron Oxide CI 77499

Questions:

Call (352) 589-0139

Package Labeling:

Bottle

SHEER DAILY WEAR FACE PROTECTION MINERAL BASED SUNSCREEN SPF 16
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82328-0012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	175 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
COCONUT OIL (UNII: Q9L0O73W7L)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SANDALWOOD OIL (UNII: X7X01WMQ5F)
XANTHAN GUM (UNII: TTV12P4NEE)
JOJOBA OIL (UNII: 724GKU717M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82328-0012-0	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/01/2021

Labeler - REJUVA MINERALS INC (014406614)

Name	Address	ID/FEI	Business Operations
Establishment
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(82328-0012)

Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16