Post Rays Blemish Balm: Package Insert and Label Information

POST RAYS BLEMISH BALM- titanium dioxide, octinoxate and zinc oxide cream
Humex,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.

Zinc Oxide (3.5%)————————–Sunscreen

Titanium Dioxide (5.99%)—————Sunscreen

Octinoxate (6.5%)————————-Sunscreen

packaging with label in place
(click image for full-size original)

Uses

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

▪ Appy liberally 15 minutes before sun exposure
▪ Reapply at least every 2 hours
▪ Use a water-resistant sunscreen if swimming or sweating
▪ Children under 6 months of age: ask a doctor

Other Information

▪ protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water, Cetyl Ethylhexanoate, Propylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Isononyl Isononanoate, Clydomethicones, Sorbitan Sesquioleate, Talc, Mineral Oil, Arbutin, Medium-Chain Triglyceride, Microcrystalline Wax, Magnesium Sulfate, Dimethicone, Bentoquatam, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Phenoxyethanol, Ferric Oxide Yellow, Ferrosoferric Oxide, Ferric Oxide Red, Aluminum Hydroxide, PEG-10 Dimethicone Crosspolymer, Triethoxycaprylylsilane, Allantoin, Adenosine, Purslane, Aloe Vera Leaf, Chamaemelum Nobile Flower, Hyaluronate Sodium

label in place

POST RAYS BLEMISH BALM
zinc oxide, titanium dioxide, octinoxate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76344-8003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 5.98878 g in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 6.5 g in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 3.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER 0.5 g in 100 g
FERROSOFERRIC OXIDE 0.29792 g in 100 g
FERRIC OXIDE RED 0.25872 g in 100 g
CETYL ETHYLHEXANOATE 7 g in 100 g
TRIETHOXYCAPRYLYLSILANE 0.1482 g in 100 g
ALLANTOIN 0.1 g in 100 g
FERRIC OXIDE YELLOW 0.3136 g in 100 g
DIMETHICONE 0.95 g in 100 g
ADENOSINE 0.04 g in 100 g
ALOE VERA LEAF 0.01 g in 100 g
HYALURONATE SODIUM 0.00005 g in 100 g
PROPYLENE GLYCOL 6 g in 100 g
PURSLANE 0.01 g in 100 g
CHAMAEMELUM NOBILE FLOWER 0.01 g in 100 g
ALUMINUM HYDROXIDE 0.18522 g in 100 g
TALC 2.21756 g in 100 g
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) 3 g in 100 g
ARBUTIN 2 g in 100 g
MEDIUM-CHAIN TRIGLYCERIDES 1.8 g in 100 g
MICROCRYSTALLINE WAX 1.5 g in 100 g
MAGNESIUM SULFATE, UNSPECIFIED FORM 1 g in 100 g
PHENOXYETHANOL 0.40003 g in 100 g
SORBITAN SESQUIOLEATE 2.5 g in 100 g
MINERAL OIL 2 g in 100 g
CYCLOMETHICONE 5 2.9 g in 100 g
ISONONYL ISONONANOATE 3 g in 100 g
BENTOQUATAM 0.8 g in 100 g
Product Characteristics
Color brown (Yellowish Brown) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76344-8003-2 1 TUBE in 1 BOX contains a TUBE (76344-8003-1)
1 NDC:76344-8003-1 50 g in 1 TUBE This package is contained within the BOX (76344-8003-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/01/2019
Labeler — Humex,Inc (017945311)
Establishment
Name Address ID/FEI Operations
HANACOS CO., LTD. 690177857 manufacture (76344-8003)

Revised: 01/2020 Humex,Inc

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.