SUDDEN CHANGE INTENSIVE RESTORATION DAILY MOISTURIZER SPF 15- zinc oxide, octinoxate cream 
CCA Industries 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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Sudden Change Intensive Restoration Daily Moisturizer SPF 15

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

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OuterPackage2
OuterPackage3
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SUDDEN CHANGE INTENSIVE RESTORATION DAILY MOISTURIZER SPF 15 
zinc oxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-1082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LEVOMENOL (UNII: 24WE03BX2T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
JOJOBA OIL (UNII: 724GKU717M)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61543-1082-250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/201112/31/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/18/201112/31/2011
Labeler - CCA Industries Inc (106771041)
Establishment
NameAddressID/FEIBusiness Operations
CSR Cosmetic Solutions Inc.243501959manufacture(61543-1082)

Revised: 3/2019
 
CCA Industries Inc