SUMMER READY INNOVATIVE SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream cream
JADA Wellness, LLC

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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Summer Ready Innovative Sunscreen

Avobenzone 3%

Homosalate 6%

Octisalate 4%

Octocrylene 7%

Sunscreen

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 Spectrum SPF value of 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

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

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

TROLAMINE

ETHYLHEXYL METHOXYCRYLENE

ETHYLHEXYL PALMITATE

ETHYLHEXYLGLYCERIN

PANTHENOL

PHENOXYETHANOL

SORBITAN SESQUIOLEATE

STEARIC ACID

STEARYL ALCOHOL

CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE

MEDIUM-CHAIN TRIGLYCERIDES

CARBOMER INTERPOLYMER TYPE A (55000 CPS)

WATER

EDETATE DISODIUM ANHYDROUS

Summer Ready

SUMMER READY INNOVATIVE SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73231-1901
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73231-1901-1	118 mL in 1 TUBE; Type 0: Not a Combination Product	07/19/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/19/2019	07/20/2019

Labeler - JADA Wellness, LLC (045969028)

Registrant - JADA Wellness, LLC (045969028)

Revised: 7/2020

Document Id: aafbcc3e-917b-3b1b-e053-2995a90afb0b

Set id: 8dfad32d-341d-32ad-e053-2a95a90a526a

Version: 4

Effective Time: 20200721

JADA Wellness, LLC