SPF RX - MINERAL SUNSCREEN SPF 50- zinc oxide, titanium dioxide cream 
Cal Pharma LLC

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Cal Pharma (as PLD) - SPF Rx - Mineral Sunscreen SPF 50 (55628-8626) - DELIST

ACTIVE INGREDIENTS

Zinc Oxide 7%

Titanium Dioxide 5%

Purpose

Sunscreen

USES

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer, early skin aging 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 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

- At least every 2 hours. Immediately after towel drying.

Sun Protection Measures:Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

• Children under 6 months. Ask a doctor.

INACTIVE INGREDIENTS

Benzoic Acid, C12-15 Alkyl Benzoate, Caprylic/Capric Triglycerides, Cetyl PEG/PPG-10/1 Dimethicone, Dicaprylyl Ether, Ethylhexylglycerin, Glycereth-2 Cocoate, Glycerin, Isostearic Acid, Stearyl/Octyldodecyl Citrate Crosspolymer, Polyhydroxystearic Acid, Propanediol, Sodium Chloride, Sodium Hyaluronate, Tocopheryl Acetate (Vitamin E Acetate), Triethoxycaprylylsilane, Water

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

SPF Rx - Mineral Sunscreen SPF 50 PDP

SPF RX - MINERAL SUNSCREEN SPF 50 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55628-8626
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
OCTYLDODECYL STEARATE (UNII: K6F16QGO28)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PROPANEDIOL (UNII: 5965N8W85T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55628-8626-4120 g in 1 TUBE; Type 0: Not a Combination Product07/30/201712/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/30/201712/31/2023
Labeler - Cal Pharma LLC (078721283)

Revised: 3/2024
 
Cal Pharma LLC