Drug Labeling and Warnings

Drug Details

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ECLIPSE SPF 50 ALL SHADES- titanium dioxide, zinc oxide lotion 
SCIENCE OF SKINCARE LLC

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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Active Ingredients

TITANIUM DIOXIDE – 5.20%

Zinc Oxide – 1.10%

PURPOSE

SUNSCREEN

USES

Helps hydrate and prevent sunburn.
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
  • REAPPLY:
  • AFTER 40 MINUTES OF SWIMMING OR SWEATING
  • IMMEDIATELY AFTER TOWEL DRYING
  • AT LEAST EVERY 2 HOURS

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
o limit time in the sun, especially from 10 a.m.-2 p.m.
o wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.

Questions or Comments?

Call Customer Care at (888) 804-4447

Inactive Ingredients

1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alumina, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Disodium EDTA, Dimethicone, Glyceryl Stearate, Methicone, Octyldodecyl Neopentanoate, PEG-100 Stearate, Polyhydroxystearic Acid, Sorbitan Laurate, Styrene/Acrylates Copolymer, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, VP/Eicosene Copolymer, Water/Aqua/Eau, Xanthan Gum +/- Iron Oxides.

Eclipse SPF-50_Untinted

Eclipse SPF-50_Brown_Box

Eclipse SPF-50_Beige_Box

ECLIPSE SPF 50  ALL SHADES
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69219-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.2 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
ALUMINUM (UNII: CPD4NFA903)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
STYRENE (UNII: 44LJ2U959V)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69219-102-511 in 1 BOX
1NDC: 69219-102-1390 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/01/2014
Labeler - SCIENCE OF SKINCARE LLC (006251958)

Revised: 10/2014
 
SCIENCE OF SKINCARE LLC


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