Open Formula SPF 33 Sunscreen Lotion

Open Formula SPF 33 Sunscreen by

Drug Labeling and Warnings

Open Formula SPF 33 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OPEN FORMULA SPF 33 SUNSCREEN- zinc oxide lotion 
Inspec Solutions 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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Open Formula SPF 33 Sunscreen Lotion

Active ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

Uses

Helps prevent sunburn, higher SPF gives more sunburn protection

retains SPF after XX minutes of activity in the water or sweating

provides moderate protection against 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.

Highly Flammable: Do not apply or use product near heat, flame, or while smoking.

When using this product:

keep out of eyes. Rinse with water to remove.

Keep away from face to avoid breathing it.

Do not puncture or incinerate, Contents under pressure

Do not store at temperature above 120⁰F

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

When using this product:

keep out of eyes. Rinse with water to remove.

Keep away from face to avoid breathing it.

Do not puncture or incinerate, Contents under pressure

Do not store at temperature above 120⁰F

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

Behenyl Alcohol

BHT

Butyloctyl Salocylate

Caprylyl Methicone

Dimethicone

Dimethyl Capramide

Disodium EDTA

Ethylhexyl Stearate

Ethylhexylglycerin

Glyceryl Stearate

Hydrated Silicia

PEG-100 Stearate

Phenoxyethanol

Polyester-8

Sodium Polyacrylate

Styrene/ Acrylate Copolymer

Trideceth-6

Trimethylsiloxysilicate

VP/Hexadecene Copolyer

Water

Xanthan Gum

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

٠Hold container 4 to 6 inches from the skin to apply.
٠Do not spray directly into face. Spray on hands then apply to face.
٠Do not apply in windy conditions.
٠Use in a well-ventilated area.
٠For sunscreen use
٠apply to all areas of the skin exposed to the sun.
٠Reapply as needed or after towel drying, swimming, or sweating.

Open Formula SPF 33 Sunscreen

OPEN FORMULA SPF 33 SUNSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72667-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
SUCROSE LAURATE (UNII: 05Q7CD0E49)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SUCROSE STEARATE/PALMITATE ESTER (75% MONO ESTER) (UNII: L98X941W2B)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PANTHENOL (UNII: WV9CM0O67Z)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TURMERIC (UNII: 856YO1Z64F)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72667-051-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/26/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/26/2022
Labeler - Inspec Solutions LLC. (081030372)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC.081030372manufacture(72667-051)

Revised: 6/2022
 

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