TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 SUNSCREEN (TINTED)- octinoxate, octisalate, titanium dioxide and zinc oxide lotion 
Allergan, 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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Total Defense Repair Broad Spectrum SPF 34 Sunscreen Tinted
Drug Facts

Active ingredients

Octinoxate 7.5%

Octisalate 3.0%

Titanium Dioxide 3.5%

Zinc Oxide 8.0%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

Warnings

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 reach of children. 

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Squalane, Silica, Glycerin, Niacinamide, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Polygonum Aviculare Extract, Physalis Angulata Extract, Dunaliella Salina Extract, Ubiquinone, Camellia Sinensis Leaf Extract, Tremella Fuciformis Sporocarp Extract, Betaine, Melanin, Tocopheryl Acetate, Tocopherol, Hydroxyacetophenone, Batyl Alcohol, C12-15 Alkyl Benzoate, PEG-12 Dimethicone, Panthenol, Butylene Glycol, Ceteareth-20, Polyhydroxystearic Acid, Isostearic Acid, Xanthan Gum, Ethylhexylglycerin, Disodium EDTA, Aminomethyl Propanol, Caprylyl Glycol, Potassium Sorbate, Sorbic Acid, Phenoxyethanol, Iron Oxides (77491,77492,77499)

Other information

Questions or comments

www.skinmedica.com

Principal Display Panel - Carton Label

TOTAL DEFENSE
+
REPAIR
Broad Spectrum SPF 34 Sunscreen
+ INFRARED PROTECTION
TINTED
Net Wt. 6 x 1.0 Oz Travel

TOTAL DEFENSE
+ 
REPAIR
Broad Spectrum SPF 34 Sunscreen
+ INFRARED PROTECTION
TINTED
Net Wt. 6 x 1.0 Oz Travel

TOTAL DEFENSE REPAIR BROAD SPECTRUM SPF 34 SUNSCREEN (TINTED) 
octinoxate, octisalate, titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-5497
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SQUALANE (UNII: GW89575KF9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
BATILOL (UNII: 39YR661C4U)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BETAINE (UNII: 3SCV180C9W)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
UBIDECARENONE (UNII: EJ27X76M46)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0023-5497-231 in 1 CARTON06/15/2015
165 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0023-5497-011 in 1 CARTON06/15/2015
228.4 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0023-5497-256 in 1 CARTON06/15/201506/30/2024
37.08 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:0023-5497-081 in 1 CARTON06/15/2015
4227 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/15/2015
Labeler - Allergan, Inc. (144796497)

Revised: 8/2015
Document Id: 69d29aec-0838-4a4e-9b3b-79331bf40be6
Set id: 6a996e03-907f-4e6a-b232-0892b86956b0
Version: 5
Effective Time: 20150821
 
Allergan, Inc.