MOISTURIZER MAPLE DAY SPF15- moisturizer maple day spf15 cream 
Kamins Dermatologics Inc.

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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Moisturizer Maple day Cream SPF 15

Purpose section: Sunscreen

A super emollient hydrating day cream with sunscreen to nourish deeply dry and dehydrated skin and supplement the skin’s diminished natural oils.

Uses:

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. If contact occurs, rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of the reach and sight of children.

If swallowed, seek medical assistance or contact a Poison Control Center immediately.

Directions

Apply liberally and evenly, each morning to cleansed face and neck, 15 minutes before sun exposure and as needed
Reapply at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating
Children under 6 months of ages: ask a doctor.

Storage:

Protect the product in the container from excessive heat and direct sun.
Store between 15-30 °C

Principal display Panel:

B. KAMINS

boxMoisturizer Maple day Cream SPF15

DIN 02244222

50mL / 1.7 fl.oz

MOISTURIZER MAPLE DAY SPF15 
moisturizer maple day spf15 cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE45 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM LACTATE (UNII: TU7HW0W0QT) 50 mg  in 1 g
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) 1.7 mg  in 1 g
CAPRYLYL GLYCOL (UNII: 00YIU5438U) 4 mg  in 1 g
SQUALANE (UNII: GW89575KF9) 35 mg  in 1 g
SORBIC ACID (UNII: X045WJ989B) 4 mg  in 1 g
1,1-DIPHENYLUREA (UNII: H33D27I551) 50 mg  in 1 g
WATER (UNII: 059QF0KO0R) 35.8 mg  in 1 g
WHITE PETROLATUM (UNII: B6E5W8RQJ4) 80 mg  in 1 g
GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 12.5 mg  in 1 g
PEG-75 STEARATE (UNII: OT38R0N74H) 12.5 mg  in 1 g
CETETH-20 (UNII: I835H2IHHX) 12.5 mg  in 1 g
STEARETH-20 (UNII: L0Q8IK9E08) 12.5 mg  in 1 g
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) 20 mg  in 1 g
ACER SACCHARUM LEAF (UNII: VP8WP1ASR7) 50 mg  in 1 g
TOCOPHEROL (UNII: R0ZB2556P8) 10 mg  in 1 g
CHOLESTEROL (UNII: 97C5T2UQ7J) 10 mg  in 1 g
MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51) 4.3 mg  in 1 g
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 40 mg  in 1 g
FRAGRANCE GREEN APPLE ORC2001072 (UNII: U9GH30P956) 2.1 mg  in 1 g
BOVINE TYPE II COLLAGEN (TRACHEAL CARTILAGE) (UNII: 76TK29UQEZ) 40 mg  in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN) 5 mg  in 1 g
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 15 mg  in 1 g
SODIUM CHLORIDE DIHYDRATE (UNII: 70521YQ49G) 10 mg  in 1 g
RETINOL (UNII: G2SH0XKK91) 0.9 mg  in 1 g
PHENOXYETHANOL (UNII: HIE492ZZ3T) 4 mg  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63550-108-0150 g in 1 BOX; Type 0: Not a Combination Product11/01/2001
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/2001
Labeler - Kamins Dermatologics Inc. (254050784)
Registrant - Odan Laboratories Ltd (208585604)
Establishment
NameAddressID/FEIBusiness Operations
Odan Laboratories Ltd208585604manufacture(63550-108) , analysis(63550-108)

Revised: 12/2022
Document Id: eecaf2b7-a8fc-0219-e053-2a95a90a387a
Set id: b63443c2-d889-7548-e053-2995a90a0f40
Version: 3
Effective Time: 20221201
 
Kamins Dermatologics Inc.