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

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Cal Pharma (as PLD) - SPF Rx - Ultra-Clear Daily Skin Hydrator SPF 50 (55628-8585) - DELIST

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.

UC_SPF Rx_Ultra-Clear Daily Skin Hydrator SPF 50

SPF RX - ULTRA-CLEAR DAILY SKIN HYDRATOR SPF 50 
zinc oxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55628-8585
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55628-8585-08 g in 1 BOTTLE; Type 0: Not a Combination Product07/31/201712/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/31/201712/31/2023
Labeler - Cal Pharma LLC (078721283)

Revised: 3/2024
 
Cal Pharma LLC