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

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Cal Pharma (as PLD) - SPF Rx - Anti-Aging Sunscreen SPF 30 (55628-8477) - DELIST

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.

LBL_Anti-Aging_SPF 30_Primary_4oz

SPF RX - ANTI-AGING SUNSCREEN SPF 30 
avobenzone, octisalate, octocrylene, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55628-8477
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.75 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.75 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
(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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55628-8477-4120 g in 1 TUBE; 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