OTC Medication Information: CYZONE SUN BY ME

CYZONE SUN BY ME- octinoxate, oxybenzone, octisalate and titanium dioxide lotion
Ventura Corporation Limited

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.

Drug Facts

Active Ingredients Purpose
Octinoxate 7.5 % sunscreen
Octisalate 5.0 % sunscreen
Oxybenzone 5.0% sunscreen
Titanium dioxide 0.948% sunscreen

Uses

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Provides moderate protection against sunburn.
  • Retains SPF after 40 minutes of activity in the water.

Warnings

For external use only.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 20 minutes before sun exposure and as needed

Other information

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

Inactive ingredients

Aqua (water),dicaprylyl carbonate, c12-15 alkyl benzoate, dimethicone, cetearyl alcohol, vp/eicosene copolymer, potassium cetyl phospate, trimethylsiloxysilicate, titanium dioxide, phenoxyethanol, isopropil myristate glyceryl stearate, panthenol, peg-100 stearate, methylparaben, ceteareth-20, xanthan gum, parfum (fragance), propylparaben, propylene glycol, polysorbate 40, ci77019(mica), silica, triethanolamine, methicone, acrylates/c10-30 alkyl acrylate crosspolymer, tetrasodium edta, daucuscarotasativa root extract(daucus carota sativa (carrot) root extract), aloe barbadensis leaf juice, butylparaben, ethylparaben, isobutylparaben, ci 77491(iron oxides), ci 19140 (yellow5), ci 14700 (red4), cocos nucifera (coconut) oil, gardenia tahitensis flower, gardenia tahitensis flower extract ci42090 (blue 1).

PRINCIPAL DISPLAY PANEL — 120 ml Bottle Label

15 FPS
golden bronze

120 ml e (4 fl oz.)

s un
by me

cy°zone

PRINCIPAL DISPLAY PANEL -- 120 ml Bottle Label
(click image for full-size original)
CYZONE SUN BY ME
octinoxate, oxybenzone, octisalate, and titanium dioxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-110
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 0.075 g in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone 0.05 g in 1 mL
Octisalate (Octisalate) Octisalate 0.05 g in 1 mL
Titanium dioxide (Titanium dioxide) Titanium dioxide 0.00948 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
dicaprylyl carbonate
c12-15 alkyl benzoate
dimethicone
cetostearyl alcohol
phenoxyethanol
isopropyl myristate
glyceryl monostearate
panthenol
polyoxyl 100 stearate
methylparaben
polyoxyl 20 cetostearyl ether
xanthan gum
propylparaben
propylene glycol
polysorbate 40
mica
silicon dioxide
trolamine
carbomer interpolymer type a (55000 cps)
edetate sodium
carrot
aloe vera leaf
butylparaben
ethylparaben
isobutylparaben
ferric oxide red
FD&C yellow no. 5
FD&C red no. 4
coconut oil
FD&C blue no. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13537-110-13 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE (13537-110-12)
1 NDC:13537-110-12 120 mL in 1 BOTTLE This package is contained within the CARTON (13537-110-13)
2 NDC:13537-110-06 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE (13537-110-05)
2 NDC:13537-110-05 5 mL in 1 BOTTLE This package is contained within the CARTON (13537-110-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/22/2011
Labeler — Ventura Corporation Limited (602751344)
Establishment
Name Address ID/FEI Operations
BelStar, S.A. 880160197 MANUFACTURE

Revised: 11/2010 Ventura Corporation Limited

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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