SPF RX - ANTI-AGING SUNSCREEN SPF 30- avobenzone, octisalate, octocrylene, oxybenzone cream

SPF Rx - Anti-Aging Sunscreen SPF 30 by

Drug Labeling and Warnings

SPF Rx - Anti-Aging Sunscreen SPF 30 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

Avobenzone 2.75%

Octisalate 4.75%

Octocrylene 2.80%

Oxybenzone 4.25%

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/C12-22 Alkyl Methacrylate Copolymer, Aleurites Moluccana Seed Oil, Allantoin, Aloe Barbadensis Leaf Extract, Butyloctyl Salicylate, C12-13 Alcohols, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Cetearyl Alcohol, Cetyl Phosphate, Cyclopentasiloxane, Dimethicone, Ethylhexylglycerin, Glycerin, Helianthus Annuus Seed Oil, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Macadamia Ternifolia Seed Oil, Magnesium Silicate, Methylisothiazolinone, Phenoxyethanol, Polysorbate 60, Squalane, Tetrasodium EDTA, Tocopherol, Tocopheryl Acetate, Water, Xanthan Gum

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF RX - ANTI-AGING SUNSCREEN SPF 30 
avobenzone, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55628-8477
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.75 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.75 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
C12-13 ALCOHOLS (UNII: T7ZJT3I9X2)
DODECYL BENZOATE (UNII: N4F51K239A)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL PHOSPHATE (UNII: VT07D6X67O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
MACADAMIA OIL (UNII: 515610SU8C)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SQUALANE (UNII: GW89575KF9)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55628-8477-4	120 g in 1 TUBE; 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(55628-8477)