MINERAL TINTED FACE SUNSCREEN SPF 30 - LIGHT/ MEDIUM- zinc oxide and titanium dioxide cream 
MINERAL TINTED FACE SUNSCREEN SPF 30 - MEDIUM/ DARK- zinc oxide and titanium dioxide cream 
Unsun Cosmetics

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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Mineral Tinted Face Sunscreen SPF 30

Drug Facts

Medicinal ingredientsPurpose
Titanium dioxide 5.5%Sunscreen
Zinc oxide 6.5%Sunscreen

Uses

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 use on 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

Adults and children over 6 months of age: Apply liberally and evenly 15 minutes before sun exposure. Reapply after 80 minutes of swimming or perspiring heavily or immediately after towel drying or washing, 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 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.

Non-medicinal ingredients

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Isoamyl Laurate, Glycerin, Polyglyceryl-2 Sesquioleate, Coconut Alkanes, Polyglyceryl-3 Ricinoleate, Crambe Abyssinica (Abyssinian) Seed Oil, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Heptyl Undecylenate, Alumina, Stearic Acid, Magnesium Sulfate, Sodium Chloride, Coco-Caprylate/Caprate, Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter, Carthamus Tinctorius (Safflower) Seed Oil, Aloe Barbadensis Leaf Juice, Beeswax/Cera Alba/Cire d' Abeille, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Olea Europaea (Olive) Fruit Oil, Ascorbic Acid, Beta Vulgaris (Beet) Root Extract, Citric Acid, Citrus Aurantium Amara (Bitter Orange) Fruit Extract, Citrus Aurantium Sinensis Peel Extract, Citrus Reticulata (Tangerine) Fruit Extract, Glycine Soja (Soybean) Oil, Hydrolyzed Corn Starch, Lactic Acid, p-Anisic Acid, Tocopherol, Triethoxycaprylylsilane, Iron Oxides (CI 77491, CI 77492, CI 77499).

Other information

PRINCIPAL DISPLAY PANEL - 50 mL Tube Label - Light Medium

unsun

MINERAL TINTED
FACE SUNSCREEN
LOTION

30

BROAD SPECTRUM
SPF 30

WATER RESISTANT
(80 MINUTES)

NPN xxxxx

LIGHT - MEDIUM

1.7 FL OZ | 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Label - Light Medium

PRINCIPAL DISPLAY PANEL - 50 mL Tube Label - Medium Dark

unsun

MINERAL TINTED
FACE SUNSCREEN
LOTION

30

BROAD SPECTRUM
SPF 30

WATER RESISTANT
(80 MINUTES)

NPN xxxxx

MEDIUM - DARK

1.7 FL OZ | 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Label - Medium Dark
MINERAL TINTED FACE SUNSCREEN SPF 30 - LIGHT/ MEDIUM 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73455-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.055 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
Heptyl Undecylenate (UNII: W77QUB6GXO)  
Product Characteristics
ColorBROWN (tan) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73455-011-281 in 1 BOX04/15/2019
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/15/2019
MINERAL TINTED FACE SUNSCREEN SPF 30 - MEDIUM/ DARK 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73455-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.055 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
Heptyl Undecylenate (UNII: W77QUB6GXO)  
Product Characteristics
ColorBROWN (beige) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73455-111-301 in 1 BOX04/15/2019
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/15/2019
Labeler - Unsun Cosmetics (080766704)
Establishment
NameAddressID/FEIBusiness Operations
Pack On Demand610511326MANUFACTURE(73455-011, 73455-111)

Revised: 3/2022
Document Id: 880b7e4c-d962-466f-a29e-76d03df93f72
Set id: a2a7b6f0-8f2c-4654-977d-955f535d7ca4
Version: 2
Effective Time: 20220324
 
Unsun Cosmetics