SPF RX - MINERAL SUNSCREEN SPF 40- zinc oxide, titanium dioxide cream 
Cal Pharma LLC

----------

Cal Pharma (as PLD) - SPF Rx - Mineral Sunscreen SPF 40 (55628-9228) - DELIST

ACTIVE INGREDIENTS

Zinc Oxide 20%

Titanium Dioxide 1%

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

Acrylates Copolymer, Benzoic Acid, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglycerides, Cera Alba (Beeswax), Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexylglycerin, Glycereth-2 Cocoate, Glyceryl Stearate, Hexyl Laurate, Isopropyl Palmitate, Isostearic Acid, Magnesium Aluminum Silicate, Niacinamide, PEG-100 Stearate, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Sorbitan Monostearate, Steareth-21, Tapioca Starch, Water, Xanthan Gum

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

Label_SPF Rx - Mineral SPF 40_Primary 4oz

SPF RX - MINERAL SUNSCREEN SPF 40 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55628-9228
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
WHITE WAX (UNII: 7G1J5DA97F)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARETH-21 (UNII: 53J3F32P58)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55628-9228-4120 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: 4/2024
 
Cal Pharma LLC