TINTED DAILY WEAR FACE PROTECTION MINERAL BASED SUNSCREEN SPF 16 - FAIR LIGHT- zinc oxide cream

Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair Light by

Drug Labeling and Warnings

Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair Light by is a Otc medication manufactured, distributed, or labeled by REJUVA MINERALS INC, Columbia Cosmetics Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Oil, Sorbitan Stearate, Polyglyceryl-10 Laurate, Ricinus Communis (Castor) Seed Oil, Glycerin*, Titanium Dioxide CI 77891, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, Magnesium Sulfate, Gluconolactone, Triethoxycaprylylsilane, Iron Oxide CI 77492, Sodium Benzoate, Santalum Album (Sandalwood) Oil, Xanthan Gum, Iron Oxide CI 77491, Simmondsia Chinensis (Jojoba) Seed Oil*, Cocos Nucifera (Virgin Coconut) Oil*, Iron Oxide CI 77499, Calcium Gluconate, Sodium Hyaluronate, Palmitoyl Tetrapeptide-7, Palmitoyl Hexapeptide-12. *Certified Organic.

Questions:

Call (352) 589-0139

Package Labeling:

Rejuva
Minerals

Tinted
DAILY WEAR
Face
Protection
SPF 16
Broad Spectrum
UVA and UVB
Protection

Zinc Oxide

Firming Peptides
and
Hyaluronate Acid

FAIR-LIGHT

50 ml (1.69 oz)

INGREDIENTS AND APPEARANCE

TINTED DAILY WEAR FACE PROTECTION MINERAL BASED SUNSCREEN SPF 16 - FAIR LIGHT 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82328-0013
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
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)
IRON OXIDES (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82328-0013-1	1 in 1 CARTON	01/02/2025
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/02/2025

Labeler - REJUVA MINERALS INC (014406614)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(82328-0013)