Label: EEZY SUN SPF 30- meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream
EEZY SUN SPF 50- meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70116-001-01, 70116-002-01 - 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 December 14, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Actives
- Inactives
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Dosage and Administration
Directions
Apply liberally 15 minutes before sun exposure Reapply
PLEASE RECYCLE
DISTRIBUTED BY SANRIA26 (PTY) LTD 9428 ASHFORD PLACE BRENTWOOD, TN 37027 INFO@EEZYSUN.COM PRODUCT OF SOUTH AFRICA
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:
Limit 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 docto
- Warnings
- Product Label SPF 30
- Product Label SPF 50
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INGREDIENTS AND APPEARANCE
EEZY SUN SPF 30
meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70116-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE 30 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 50 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 90 mg in 1 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:70116-001-01 8 mL in 1 POUCH; Type 0: Not a Combination Product 12/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/14/2017 EEZY SUN SPF 50
meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70116-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE 50 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 80 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 70 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 110 mg in 1 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:70116-002-01 8 mL in 1 POUCH; Type 0: Not a Combination Product 12/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/14/2017 Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436) Establishment Name Address ID/FEI Business Operations BIO EARTH MANUFACTURING (PTY) LTD 639768436 manufacture(70116-001, 70116-002)