REMEDY SPF 30 by RENU LABORATORIES, INC. REMEDY SPF 30

REMEDY SPF 30 by

Drug Labeling and Warnings

REMEDY SPF 30 by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 SPF 30 
zinc oxide sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-645
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21 g  in 112 g

Inactive Ingredients
Ingredient Name	Strength
.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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-645-01	1 in 1 BOX	06/07/2021	08/15/2022
1	NDC: 76348-645-04	112 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/07/2021	08/15/2022

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-645)

Revised: 8/2022

Document Id: e778b553-5d4b-49e3-e053-2995a90ae750

34390-5

Set id: c46c2513-976f-082e-e053-2a95a90afa78

Version: 2

Effective Time: 20220830