Label: EEZY PRO SPF50- meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream
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- NDC Code(s): 70116-009-01
- Packager: BIO EARTH MANUFACTURING (PTY) LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated March 16, 2020
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- Active Ingredients
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
-
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 value of 15 or higher and other sun protection measures including:
- Limited time in the sun, espesially from 10 a.m - 2 p.m
- Wear long-sleeved shirts, pants, hats and sunglasses
- Children under 6 months of age: ask a doctor
- Inactive ingredients
- Other information
- Product Label
-
INGREDIENTS AND APPEARANCE
EEZY PRO SPF50
meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70116-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE 5 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 11 g in 100 mL Inactive Ingredients Ingredient Name Strength BULBINE FRUTESCENS WHOLE (UNII: M2U1C7UW6Y) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLPARABEN (UNII: Z8IX2SC1OH) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) VITAMIN A (UNII: 81G40H8B0T) WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70116-009-01 10 in 1 PACKET 03/17/2020 1 8 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/17/2020 Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436) Establishment Name Address ID/FEI Business Operations BIO EARTH MANUFACTURING (PTY) LTD 639768436 manufacture(70116-009)
