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.

Package Labeling:

Label4

SUDDEN CHANGE DERMA RENEWAL COMPLEX
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61543-0003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
HYDROGENATED OLIVE OIL (UNII: 53839415GI)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CERAMIDE NG (UNII: C04977SRJ5)
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
XANTHAN GUM (UNII: TTV12P4NEE)
ALLANTOIN (UNII: 344S277G0Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LEVOMENOL (UNII: 24WE03BX2T)
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61543-0003-0	1 in 1 BOX	04/01/2018
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/01/2018

Labeler - CCA Industries Inc. (106771041)

Sudden Change Derma Renewal Complex