SUGAR BLOOM TINTED TREATMENT SUNSCREEN SPF 15- octinoxate paste 
Fresh 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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SUGAR BLOOM TINTED LIP TREATMENT SUNSCREEN SPF 15

Drug Facts

Active Ingredients

Octinoxate 6.74%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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

Directions

For sunscreen use:
• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: Ask a doctor

Other Information

Protect this product in container from excessive heat and direct sun

Questions or Comments?

Call toll free 1(800)FRESH-20 Monday-Friday (9 a.m. to 5p.m EST)

Inactive Ingredients

Cera Alba (Beeswax), Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrogenated Olive Oil Decyl Esters, Vitis Vinifera (Grape) Seed Oil, Parfum (Fragrance), Synthetic Fluorphlogopite, Copernicia Cerifera (Carnauba) Wax, Persea Gratissima (Avocado) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Passiflora Incarnata Seed Oil, Sucrose Tetrastearate Triacetate, Ribes Nigrum (Black Currant) Seed Oil, Tocopherol, Ascorbyl Tetraisopalmitate, Ascorbyl Palmitate, Ammonium Glycyrrhizate, Polyglyceryl- 3 Polyricinoleate, Vanillin, BHT, Propyl Gallate, Limonene, Citral, Benzyl Alcohol, Linalool, Geraniol [May Contain: CI 15850 (Red 6, Red 7, Red 7 Lake), CI 15985 (Yellow 6, Yellow 6 Lake), CI 19140 (Yellow 5, Yellow 5 Lake), CI 42090 (Blue 1 Lake), CI 45410 (Red 27, Red 27 Lake, Red 28 Lake), CI 77491, CI 77492, CI 77499 (Iron Oxides), CI 77891 (Titanium Dioxide)] <12339/Z>

Package Labeling:

Outer Package5Inner Package5Box

SUGAR BLOOM TINTED TREATMENT SUNSCREEN SPF 15 
octinoxate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42406-044
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE67.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
CASTOR OIL (UNII: D5340Y2I9G)  
JOJOBA OIL (UNII: 724GKU717M)  
HYDROGENATED OLIVE OIL DECYL ESTERS (UNII: XQ691JJ99N)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)  
SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)  
RIBES NIGRUM SEED OIL (UNII: GKE1188837)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
VANILLIN (UNII: CHI530446X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
CITRAL (UNII: T7EU0O9VPP)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
GERANIOL (UNII: L837108USY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42406-044-011 in 1 CARTON11/01/201807/01/2022
14.3 g in 1 BOX; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/201807/01/2022
Labeler - Fresh Inc (021403729)

Revised: 12/2022
 
Fresh Inc