Label: MINERAL SUNSCREEN SPF-50- titanium dioxide, zinc oxide lotion
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- NDC Code(s): 73088-104-14
- Packager: TUBBY TODD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 12, 2021
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
- Apply generously 15 minutes before sun exposure and as needed.
- 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 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".
- Children under 6 months of age: ask a doctor
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INACTIVE INGREDIENT
Water, Caprylic Capric Triglycerides, C12-C15 Alkyl Benzoate, Triethoxycaprylsilane, Glycerin, Propanediol, Dicaprylyl Ether, lsostearic Acid, Polyhydroxystearic Acid, Octyldodecyl Stearyl Citrate Crosspolymer, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Sodium Hyaluronate
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MINERAL SUNSCREEN SPF-50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73088-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 7 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) DICAPRYLYL ETHER (UNII: 77JZM5516Z) ISOSTEARIC ACID (UNII: X33R8U0062) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) OCTYLDODECYL STEARATE (UNII: K6F16QGO28) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZOIC ACID (UNII: 8SKN0B0MIM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERETH-2 COCOATE (UNII: JWM00VS7HC) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73088-104-14 118 mL in 1 TUBE; Type 0: Not a Combination Product 05/21/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/21/2019 Labeler - TUBBY TODD (052545299) Establishment Name Address ID/FEI Business Operations Health Specialty 794053863 manufacture(73088-104)
