OTC Medication Information: Suntan Lotion

SUNTAN LOTION — octinoxate, oxybenzone and titanium dioxide lotion
Tri-Coastal Design Company 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.

Active Ingredient

Octyl Methoxycinnamate 7%

Oxybenzone 6%

Titanium Dioxide 1%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

  • Keep out of eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

  • irritation develops

Keep out of reach of children

  • If swallowed, get medical help promptly or contact Poison Control immediately.

Directions

  • Apply generously and evenly before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Ask doctor before use on children under 6 months of age

Inactive Ingredients

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cylcomethicone, DC Orange 4, Disodium EDTA, FDC Blue 1, FDC Yellow 5, Fragrance, Glycerin, Imidazolidinyl Urea, Isopropyl Myristate, Methylparaben, Potassium Cetyl Phosphate, Propylparaben, Tocopheryl Acetate, Water ( Aqua), Xanthan Gum

Package Label

Package Label
image of package label
(click image for full-size original)

image of package label
SUNTAN LOTION
octinoxate oxybenzone titanium dioxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49852-201
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7 mL in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 6 mL in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
CETOSTEARYL ALCOHOL
CYCLOMETHICONE
D&C ORANGE NO. 4
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
GLYCERIN
ISOPROPYL MYRISTATE
METHYLPARABEN
POTASSIUM CETYL PHOSPHATE
PROPYLPARABEN
WATER
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49852-201-60 60 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 02/28/2010
Labeler — Tri-Coastal Design Company Inc. (609734900)
Establishment
Name Address ID/FEI Operations
Guangzhou St Eva Fine Chemical Co Ltd 528039793 manufacture

Revised: 02/2010 Tri-Coastal Design Company Inc.

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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