ALDANA SKIN LIFE - SUNSCREEN BROAD SPECTRUM SPF 55 WATER RESISTANT (80 MINS.)- octinoxate and zinc oxide lotion 
Cosmetic Solutions LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aldana Skin Life - Sunscreen Broad Spectrum SPF 55 Water Resistant (80 Mins.)

DRUG FACTS:

ACTIVE INGREDIENTS

Octinoxate 7.5%, Zinc Oxide 4.8%

PURPOSE

Sunscreen

USES

Helps prevent sunburn.

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 and evenly 15 minutes before sun exposure. 1Reapply: At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and 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:


1
For children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS

Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 60 G Bottle Label

ALDANA
SKIN LIFE

uv
PROTECTIVE

SUNSCREEN

BROAD SPECTRUM SPF 55

WATER RESISTANT (80 MINS.)

60 G (NET WT. 2 OZ)

PRINCIPAL DISPLAY PANEL - 60 G Bottle Label
ALDANA SKIN LIFE - SUNSCREEN BROAD SPECTRUM SPF 55 WATER RESISTANT (80 MINS.) 
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-5500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE48 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTYL STEARATE (UNII: 772Y4UFC8B)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66163-5500-160 g in 1 BOTTLE; Type 0: Not a Combination Product05/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2022
Labeler - Cosmetic Solutions LLC (807907928)

Revised: 4/2022
Document Id: 0c5e1b63-460d-4346-bc50-0a04d716b38f
Set id: 31f4a47e-4394-4e14-b727-a444b92d5fb1
Version: 1
Effective Time: 20220412
 
Cosmetic Solutions LLC