UNSUN BROAD SPECTRUM SPF 30 MINERAL- titanium dioxide, zinc oxide lotion
Prime Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Everyday by Unsun Light Medium Mineral Tinted Face Sunscreen Lotion SPF 30

Active ingredients

Titanium dioxide 3 %

Zinc oxide 3 %

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

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging For external use only.

Do not useon damaged or broken skin.

When using this product avoid contact with eyes . If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, at least every 2 hours. 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 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.

Inactive ingredients

Allantoin, Alumina, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl PEG/PPG-10/1 Dimethicone, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Iron Oxides, Lavandula Angustifolia (Lavender) Oil, Linum Usitatissimum (Linseed) Seed Oil, Oenothera Biennis (Evening Primrose) Oil, PEG-10 Dimethicone, Phenoxyethanol, Plankton Extract, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Rosa Canina Seed Oil, Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

Other information

protect this product from excessive heat and direct sun.

Questions or comments?

info@unsuncosmetics.com

Everyday by Unsun Light Medium Mineral Tinted Face Sunscreen Lotion SPF 30

Principle Display Label

UNSUN BROAD SPECTRUM SPF 30 MINERAL
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0425
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	30.51 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	30.51 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
LAVENDER OIL (UNII: ZBP1YXW0H8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LINSEED OIL (UNII: 84XB4DV00W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CUCUMBER (UNII: YY7C30VXJT)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ROSA CANINA SEED (UNII: 4503R1M9UT)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALLANTOIN (UNII: 344S277G0Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SHEA BUTTER (UNII: K49155WL9Y)
WATER (UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
D&C BLACK NO. 2 (UNII: 4XYU5U00C4)

Product Characteristics
Color	brown (Beige/Gray)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0425-3	50 mL in 1 TUBE; Type 0: Not a Combination Product	10/05/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	10/05/2021

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc.		101946028	pack(58443-0425) , manufacture(58443-0425) , label(58443-0425) , analysis(58443-0425)

Revised: 10/2021

Document Id: cf700dde-1a27-73f1-e053-2a95a90a4fce

Set id: cf700dde-1a26-73f1-e053-2a95a90a4fce

Version: 1

Effective Time: 20211028

Prime Enterprises Inc.