SPF RX - ULTRA-CLEAR DAILY SKIN HYDRATOR SPF 50- zinc oxide, octinoxate cream

SPF Rx - Ultra-Clear Daily Skin Hydrator SPF 50 by

Drug Labeling and Warnings

SPF Rx - Ultra-Clear Daily Skin Hydrator SPF 50 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 9%

Octinoxate 7.5%

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.

INDICATION

SPF RX's Ultra-Clear Skin Hydrator sets a new standard in healthy skin and nourishing skin protection. It is a zinc-based broad spectrum sunscreen that not only protects against UVA and UVB rays, it has Liposhield® to shield your skin from the high energy visible light from smartphones, computer screens and other indoor light sources. Professional strength skin calming and nourishing moisture: Ultra-Clear Daily Skin Hydrator is actually a mult-functional facial product that also nourishes and hydrates your skin with a potent blend of hyaluronic acid and pure ceramides.

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

Water, Cyclopentasiloxane, PEG-10 Dimethicone, Methicone, Isododecane, Propanediol, Caprylic/Capric Triglycerides, Isodecyl Neopentanoate, Dimethicone/bis-Isobutyl PPG-20 Crosspolymer, Stearyl/Octyldodecyl Citrate Crosspolymer, Tapioca Starch, Polymethylsilsesquioxane, Glycerin, Isostearic Acid, Polyhydroxystearic Acid, Dimethicone, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Dicaprylyl Ether, Dehydroxanthan Gum, Carthamus Tinctorius Seed Oil, Melanin, Sodium Hyaluronate, Silicon Dioxide, Tocopheryl Acetate, Dipotassium Glycyrrhizinate, Porphyridium Cruentum Extract, Eucalyptus Globulus Leaf Extract, Zingiber Officinale Root Extract, Gaultheria Procumbens Leaf Extract, Avena Sativa Kernel Extract, Allantoin, Ceramide 3

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF RX - ULTRA-CLEAR DAILY SKIN HYDRATOR SPF 50 
zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55628-8585
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
METHICONE (20 CST) (UNII: 6777U11MKT)
ISODODECANE (UNII: A8289P68Y2)
PROPANEDIOL (UNII: 5965N8W85T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
OCTYLDODECYL STEARATE (UNII: K6F16QGO28)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
GLYCERIN (UNII: PDC6A3C0OX)
ISOSTEARIC ACID (UNII: X33R8U0062)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
SAFFLOWER OIL (UNII: 65UEH262IS)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
GINGER (UNII: C5529G5JPQ)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
OAT (UNII: Z6J799EAJK)
ALLANTOIN (UNII: 344S277G0Z)
CERAMIDE 3 (UNII: 4370DF050B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55628-8585-0	8 g in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/31/2017

Labeler - Cal Pharma LLC (078721283)

Registrant - Cal Pharma LLC (078721283)

Establishment
Name	Address	ID/FEI	Business Operations
Health Specialty		794053863	manufacture(55628-8585)