REMEDY SPF 30- zinc oxide sunscreen lotion 
RENU LABORATORIES, 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.

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REMEDY SPF 30

Active Ingredient

Zinc Oxide 18.75 percent

Purpose

Sunscreen

Uses

  • Helps prevent sunburn if used as directed with other sun protection measures (see Directions)
  • decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

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 right away

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply • after 80 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 specrum value of SPF 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age. Ask a doctor

Other information

  • protect this product from excessive heat and direct sun
  • may stain some fabrics

Inactive Ingredients: Benzyl Alcohol, Cannabidiol (CBD) Hemp-derived, Cannabigerol (CBG) Hemp-derived, Cannabis sativa (Hemp) Seed oil with a proprietary mix of terpenes (alpha-bisabolol, alpha-humulene, alpha-pinene, alpha-terpinene, beta-caryophyllene, beta-myrcene, beta-pinene, caryophyllene oxide, cis-beta-ocimene, D-limonene, eucalyptol, gamma-terpinolene, trans-nerolidol), Caprylic-Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Coco-Caprylate, Dehydroacetic Acid, Deionized Water, Isostearic Acid,

Lecithin, Microcrystalline Cellulose, Panthenol, Polyglyceryl-3, Polyricinoleate, Polyhydrostearic Acid, Silica, Sodium Phytate, Sorbitan Olivate, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, Xanthan Gum.

Questions? remedycbdcbg.com

REMEDY 4.0 oz. SPF TUBE

REMEDY 4.0 oz. SPF TUBE

REMEDY SPF BOX

REMEDY SPF 30 
zinc oxide sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-645
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21 g  in 112 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-PINENE (UNII: JPF3YI7O34)  
MYRCENE (UNII: 3M39CZS25B)  
.GAMMA.-TERPINENE (UNII: 4YGF4PQP49)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CANNABIGEROL (UNII: J1K406072N)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
WATER (UNII: 059QF0KO0R)  
HUMULENE (UNII: 54W56MD2WD)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARYOPHYLLENE (UNII: BHW853AU9H)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.BETA.-PINENE (UNII: 4MS8VHZ1HJ)  
EUCALYPTOL (UNII: RV6J6604TK)  
MENTHOL (UNII: L7T10EIP3A)  
.BETA.-OCIMENE, (3Z)- (UNII: 472UVP4R7T)  
PANTHENOL (UNII: WV9CM0O67Z)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
.ALPHA.-TERPINENE (UNII: I24X278AP1)  
XANTHAN GUM (UNII: TTV12P4NEE)  
NEROLIDOL, (6E)-(+/-)- (UNII: FG5V0N8P2H)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
GUAIOL (UNII: I7WP008A91)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
P-CYMENE (UNII: 1G1C8T1N7Q)  
TERPINOLENE (UNII: N9830X5KSL)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-645-011 in 1 BOX06/07/202108/15/2022
1NDC:76348-645-04112 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/07/202108/15/2022
Labeler - RENU LABORATORIES, INC. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
RENU LABORATORIES, INC.945739449manufacture(76348-645)

Revised: 8/2022
 
RENU LABORATORIES, INC.