ANNA LOTAN Rejuvenating Day Cream Broad Spectrum SPF 34

ANNA LOTAN Rejuvenating Day Broad Spectrum SPF 34 by

Drug Labeling and Warnings

ANNA LOTAN Rejuvenating Day Broad Spectrum SPF 34 by is a Otc medication manufactured, distributed, or labeled by Anna Lotan Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34- octinoxate, titanium dioxide cream 
Anna Lotan Ltd

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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ANNA LOTAN Rejuvenating Day Cream Broad Spectrum SPF 34

ANNA LOTAN Rejuvenating Day Cream Broad Spectrum SPF 34


Active Ingredients

Octinoxate 7.5%
Titanium Dioxide 4.4%

Purpose

Sunscreen

Uses

  • Helps to prevent sunburn
  • If used as directed with other sun protective 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 / broken skin.

When using this product

keep out of eyes. If contact occurs rinse thoroughly 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 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 or 15 higher and other protection measures including: Limit time in sun from 10 a.m.-2 p.m.
  • Wear long-sleeve shirts, pants hats and sunglasses.
  • Children under 6 months: Ask a doctor.

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Cetearyl Isononanoate, C12-15 Alkyl Benzoate, Simmondsia Chinensis (Jojoba) Seed Oil, Propanediol, Cetearyl Alcohol, Arachidyl Alcohol, Butyrosperum Parkii (Shea Butter), Dipalmitoyl Hydroxyproline, Betaine, Behenyl Alcohol, Glyceryl Stearate, Peg-100 Stearate, Glycine Soja (Soybean) Sterol, Squalane, Dimethicone, Polyacrylate-13, Cetearyl Glucoside, Sclerotium Gum, Triethanolamine, Alumina, Arachidyl Glucoside, Xylitol, Xylitylglucoside, Polyisobutene, Phenoxyethanol, Fragrance, Caprylyl Glycol, Anhydroxylitol, Chlorphenesin, Cetyl Phosphate, Disodium Edta, Simethicone, Polysorbate 20, Tocopherol, Beta-Sitosterol, Squalene.

Questions or Commerce ?

Questions or Commerce ?

info@annalotan-usa.com Tel:+972 4 6295000

Description

Product of Israel.

  • Anna Lotan Ltd. P.O. Box 166 or Akiva 30600 
  • www.annalotan-usa.com

anna lotan Rejuvenating Day Cream Broad Spectrum SPF 34 2.5 fl oz (75 mL) NEW AGE CONTROL

ANNA LOTAN Rejuvenating Day Cream Broad Spectrum SPF 34 75ml (76446-004-75)

Day Cream

ANNA LOTAN REJUVENATING DAY BROAD SPECTRUM SPF 34 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76446-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.4 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SQUALANE (UNII: GW89575KF9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
XYLITOL (UNII: VCQ006KQ1E)  
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SQUALENE (UNII: 7QWM220FJH)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PROPANEDIOL (UNII: 5965N8W85T)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
BETAINE (UNII: 3SCV180C9W)  
DOCOSANOL (UNII: 9G1OE216XY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76446-004-7575 mL in 1 BOTTLE; Type 0: Not a Combination Product06/19/201208/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/19/201208/31/2019
Labeler - Anna Lotan Ltd (600458368)
Establishment
NameAddressID/FEIBusiness Operations
Anna Lotan Ltd600458368manufacture(76446-004)

Revised: 8/2019
 
Anna Lotan Ltd