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

SPF Rx - Mineral Sunscreen SPF 40 by

Drug Labeling and Warnings

SPF Rx - Mineral Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by Cal Pharma LLC, Health Specialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55628-9228
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55628-9228-4	120 g in 1 TUBE; Type 0: Not a Combination Product	07/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/30/2017

Labeler - Cal Pharma LLC (078721283)

Registrant - Cal Pharma LLC (078721283)

Establishment
Name	Address	ID/FEI	Business Operations
Health Specialty		794053863	manufacture(55628-9228)