PREMIER TINTED MINERAL SUNSCREEN- broad spectrum spf30 cream

Premier Tinted Mineral Sunscreen by

Drug Labeling and Warnings

Premier Tinted Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Premier Plastic Surgery. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc Oxide 7.5%

Titanium Dioxide 3.2%

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 useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • 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 SPF 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

Water, Caprylic Capric Triglyceride, Cyclopentasiloxane, C30-45 Alkylcetearyl, Dimethicone Crosspolymer, C13-15 Alkane, Stearic Acid, Aluminum Hydroxide, Polyhydroxystearic Acid, Octyldodecyl Neopentanoate, Glycerin, Buddleja Davidii (Summer Lilac) Extract, Thymus Vulgaris (Thyme) Extract, Sodium Chloride, Sorbitan Oleate,Tetrasodium Edta, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Perflourodecalin, Mica, Titanium Dioxide (CI77891), Iron Oxides (CI77491).

Other Information

• protect this product from excessive heat and direct sun

Principal Display Panel -

INGREDIENTS AND APPEARANCE

PREMIER TINTED MINERAL SUNSCREEN 
broad spectrum spf30 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81341-0652
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MICA (UNII: V8A1AW0880)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
BUDDLEJA DAVIDII LEAF (UNII: X380815D32)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
C13-15 ALKANE (UNII: 114P5I43UJ)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PERFLUOROMETHYLDECALIN (UNII: VWJ68OB6TM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TETRASODIUM EDTA (UNII: MP1J8420LU)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81341-0652-6	47 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/08/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/08/2025

Labeler - Premier Plastic Surgery (080766290)