Rainbow Brod Spectrum SPF 30

Rainbow Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Rainbow Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by CoreTex Products, Pure Source. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RAINBOW BROAD SPECTRUM SPF 30- avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion 
CoreTex Products 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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Rainbow Brod Spectrum SPF 30

Active ingredients

Avobenzone 1.0%

Homosalate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 6.0%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

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 the eyes
• rinse with water to remove
  

Stop use and ask a doctor if

• rash occurs
  

Keep out of the reach of children

If swallowed get medical help or contact a Poison Control center right away.

Directions

• apply liberally  and evenly 15 minutes before sun exposure

• 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 after sun protection measures including:
  

• limit time in the sun, especially from 10:00 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats and sunglasses.

•  reapply:
• • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

• children under 6 months of age: Ask a doctor

Other information

• protect this product from excessive heat or direct sun

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, butylparaben, calendula officinalis flower extract, carbomer, chamomile recutita extract, dimethicone, dimethyl capramide,  ethylparaben, fragrance,  glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale leaf extract, tetrasodium EDTA, triethanolamine, tocopherol, tocopherol acetate, water

Questions?

Call 1-877-684-5774

Principal Display Panel

RAINBOW BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
CHAMOMILE (UNII: FGL3685T2X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PEG-100 STEARATE (UNII: YD01N1999R)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
NASTURTIUM OFFICINALE (UNII: YH89GMV676)
COMFREY LEAF (UNII: DG4F8T839X)
EDETATE SODIUM (UNII: MP1J8420LU)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-103-03	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2020	11/21/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/30/2020	11/21/2022

Labeler - CoreTex Products Inc (061944620)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products Inc		061944620	pack(65753-103)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		080354456	manufacture(65753-103)

Revised: 11/2022

Document Id: ee06a1b0-574c-4e15-e053-2995a90af4c9

34390-5

Set id: a6df6719-a23c-7b90-e053-2a95a90a5627

Version: 2

Effective Time: 20221121