Your browser does not support JavaScript! SUDDEN CHANGE INTENSIVE RESTORATION DAILY MOISTURIZER SPF 15 (ZINC OXIDE, OCTINOXATE) CREAM [CCA INDUSTRIES INC]
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SUDDEN CHANGE INTENSIVE RESTORATION DAILY MOISTURIZER SPF 15 (zinc oxide, octinoxate) cream
[CCA Industries Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Enter section text here

Active Ingredients

ZINC OXIDE 2.00%..............................SUNSCREEN
OCTINOXATE 6.00%............................SUNSCREEN

Purpose

SUNSCREEN

Uses

■ Helps prevent sunburn
■ Higher SPF gives more sunburn protection

Warnings


■ Sun Alert: UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.

■ For external use only

■ When using this product, keep out of eyes

■ Stop use and ask a doctor if rash or irritation develops and lasts

■ Keep out of reach of children

■ If swallowed, get medical help or contact a Poison Control Center immediately

Directions

■ Do not shake before using
■ To dispense the product, point the opening of the bottle into your cupped hand and slowly and carefully press the pump until you have the desired amount of product
■ Gently apply cream to face and neck daily
■ May be used alone or under makeup

■ Note: If an excessive amount of product is dispensed, reduce the amount of pressure on the pump for future applications

Inactive Ingredients

ALLANTOIN, ALOE BARBADENSIS LEAF EXTRACT, BISABOLOL, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, CAMELLIA SINENSIS EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CARPRYLYL GLYCOL, CERAMIDE, CETEARYL OLIVATE, CETYL ALCOHOL, CITRUS AURANTIUM AMARA FLOWER EXTRACT, DIMETHICONE, DISODIUM EDTA, GLYCERIN, HEXYLENE GLYCOL, HYDROGENATED OLIVE OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL UNSAPONIFIABLES, PALMITOYL OLIGOPEPTIDE, PEG-10 RAPESEED STEROL, PENTYLENE GLYCOL, PHENOXYETHANOL, POTASSIUM SORBATE, SIMMONDSIA CHINENSIS (JOJOBA) OIL, SODIUM HYALURONATE, SORBITAN OLIVATE, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, TRIBEHENIN, TRIETHOXYCAPRYLYLSILANE, WATER (AQUA), XANTHAN GUM.

Questions or Comments?

Call 1-800-595-6230
Report any issues associated with this product to the telephone number or address listed on this package

Sudden Change Intensive Restoration Daily Moisturizer SPF 15

Nothing damages your skin as much as exposure to the sun. Whether it’s prolonged exposure or just a few minutes a day, the sun causes leathery texture, uneven skin tone and brown spots, as well as lines and wrinkles.

This is the daily moisturizer that you and your sun-damaged skin have been waiting for.Sudden Change Intensive Restoration Daily Moisturizer has been exclusively formulated to help repair visible signs of sun damage, including sun spots, leathery texture and uneven skin tone. It works below the immediate surface of the skin to dramatically improve the look and feel of your skin like nothing else you have ever tried.Skin will look smoother, healthier and beautifully luminous.

Derma-Corrective Complex is a unique combination of essential ingredients that help restore sun damaged skin. This exclusive complex, with Oligopeptides, Ceramides and Antioxidants, absorbs on
contact to quickly begin repairing the skin’s natural dermal barrier to help reverse the appearance of sun damage.

■ Oligopeptides and Hyaluronic help reverse visible signs of sun damage.

■ Super antioxidants are known to neutralize free radicals and help speed natural skin repair.

■ Ceramides and Jojoba are known to help restore skin’s natural defense barrier.

■ Sunscreen with zinc oxide helps shield and protect skin from further sun damage.

For best results, use Sudden Change Intensive Restoration Daily Moisturizer in place of your regular facial moisturizer all year round. Also, apply after prolonged sun exposure. You’ll love the look of your smoother, beautifully luminous skin.

Sun Alert: UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.

Sudden Change Intensive Restoration Daily Moisturizer SPF 15 50ml

Label

OuterPackage1
OuterPackage2
OuterPackage3
OuterPackage4
SUDDEN CHANGE INTENSIVE RESTORATION DAILY MOISTURIZER SPF 15 
zinc oxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61543-1082
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE2 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
ALOE VERA LEAF 
LEVOMENOL 
BUTYLENE GLYCOL 
ALKYL (C12-15) BENZOATE 
GREEN TEA LEAF 
MEDIUM-CHAIN TRIGLYCERIDES 
CAPRYLYL GLYCOL 
CETEARYL OLIVATE 
CETYL ALCOHOL 
CITRUS AURANTIUM FLOWER 
DIMETHICONE 
EDETATE DISODIUM 
GLYCERIN 
HEXYLENE GLYCOL 
OLIVE OIL 
PALMITOYL OLIGOPEPTIDE 
PEG-10 RAPESEED STEROL 
PENTYLENE GLYCOL 
PHENOXYETHANOL 
POTASSIUM SORBATE 
JOJOBA OIL 
HYALURONATE SODIUM 
SORBITAN OLIVATE 
TETRAHEXYLDECYL ASCORBATE 
TRIBEHENIN 
TRIETHOXYCAPRYLYLSILANE 
WATER 
XANTHAN GUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61543-1082-250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/18/2011
Labeler - CCA Industries Inc (106771041)
Establishment
NameAddressID/FEIBusiness Operations
CSR Cosmetic Solutions Inc.243501959manufacture

Revised: 9/2011
 
CCA Industries Inc

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