Label: SUDDEN CHANGE INTENSIVE RESTORATION DAILY MOISTURIZER SPF 15 - zinc oxide, octinoxate cream
- NDC Code(s): 61543-1082-2
- Packager: CCA Industries Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated September 21, 2011
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- Drug Facts
Enter section text hereClose
- Active Ingredients
ZINC OXIDE 2.00%..............................SUNSCREENClose
■ Helps prevent sunburnClose
■ Higher SPF gives more sunburn protection
■ 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 lastsClose
- KEEP OUT OF REACH OF CHILDREN
■ Keep out of reach of children
■ If swallowed, get medical help or contact a Poison Control Center immediatelyClose
■ 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 applicationsClose
- 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.Close
- Questions or Comments?
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.Close
- Sudden Change Intensive Restoration Daily Moisturizer SPF 15 50ml
- INGREDIENTS AND APPEARANCE
SUDDEN CHANGE INTENSIVE RESTORATION DAILY MOISTURIZER SPF 15
zinc oxide, octinoxate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61543-1082 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 mL in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:61543-1082-2 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/18/2011 Labeler - CCA Industries Inc (106771041) Establishment Name Address ID/FEI Business Operations CSR Cosmetic Solutions Inc. 243501959 manufacture