Country: United States
Language: English
Source: NLM (National Library of Medicine)
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
CCA Industries Inc.
TOPICAL
OTC DRUG
Hepls prevent sunburn
OTC monograph not final
SUDDEN CHANGE DERMA RENEWAL COMPLEX- OCTINOXATE, ZINC OXIDE 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._ ---------- SUDDEN CHANGE DERMA RENEWAL COMPLEX _DRUG FACTS_ _ACTIVE INGREDIENT_ Octinoxate 6.00% Zinc oxide 2.00% _PURPOSE_ Sunscreen _USES:_ Hepls 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 prevent 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. Rinse with water to remove. STOP USE AND ASK A DOCTOR if rash occurs. KEEP OUT OF THE REACH OF CHILDREN. If product is swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ For sunsreen use: apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: ask a doctor. _OTHER INFORMATION_ Protect this product from excessive heat and direct sun. _INACTIVE INGREDIENTS_ WATER (AQUA), BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, SIMMONDSIA, CHINENSIS (JOJOBA) SEED OIL, GLYCERIN, DIMETHICONE, CETEARYL OLIVATE, HYDROGENATED OLIVE OIL, UNSAPONIFIABLES, CETYL ALCOHOL, SORBITAN OLIVATE, ALOE BARBADENSIS LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, TETRAHEXYLDECYL ASCORBATE, SODIUM HYALURONATE, C12-15 ALKYL BENZOATE, TRIBEHENIN, CERAMIDE NG, PEG-10 RAPESEED STEROL, PALMITOYL HEXAPEPTIDE-12, XANTHAN GUM, ALLANTOIN, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, CAPRYLYL GLYCOL, POTASSIUM SORBATE, HEXYLENE GLYCOL, BISABOLOL, FRAGRANCE, CITRUS AURANTIUM (NEROLI) FLOWER OIL _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 Read the complete document