SUGAR PUNCH TINTED LIP TREATMENT SUNSCREEN SPF 15- octinoxate paste

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Octinoxate 6.74%, Sunscreen
Available from:
Fresh, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Helps prevent sunburn
Authorization status:
OTC monograph not final
Authorization number:
42406-053-04

SUGAR PUNCH TINTED LIP 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 PUNCH 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), 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, Polyglyceryl-3 Polyricinoleate,

Ammonium Glycyrrhizate, Vanillin, BHT, Propyl Gallate, Limonene, Citral, Benzyl Alcohol, Linalool,

Geraniol, (May contain CI 15850 (Red 6 Lake, 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) <12341Z>

SUGAR PUNCH TINTED LIP TREATMENT SUNSCREEN SPF 15– 4.3g (42406-053-04)

SUGAR PUNCH TINTED LIP TREATMENT SUNSCREEN SPF 15

octinoxate paste

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4240 6 -0 53

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

6 7.4 mg in 1 g

Fresh, Inc.

Inactive Ingredients

Ingredient Name

Stre ng th

CASTO R O IL (UNII: D5340 Y2I9 G)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

HYDRO GENATED O LIVE O IL DECYL ESTERS (UNII: XQ6 9 1JJ9 9 N)

GRAPE SEED O IL (UNII: 9 30 MLC8 XGG)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

AVO CADO O IL (UNII: 6 VNO72PFC1)

MEADO WFO AM SEED O IL (UNII: 412ZHA4T4Y)

PASSIFLO RA INCARNATA SEED O IL (UNII: S0 SU5AC9 5J)

SUCRO SE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ0 45N)

RIBES NIGRUM SEED O IL (UNII: GKE118 8 8 37)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

ASCO RBYL TETRAISO PALMITATE (UNII: 47143LT58 A)

ASCO RBYL PALMITATE (UNII: QN8 3US2B0 N)

AMMO NIUM GLYCYRRHIZATE (UNII: 3VRD35U26 C)

VANILLIN (UNII: CHI530 446 X)

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

PRO PYL GALLATE (UNII: 8 D4SNN7V9 2)

LIMO NENE, ( +) - (UNII: GFD7C8 6 Q1W)

CITRAL (UNII: T7EU0 O9 VPP)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)

GERANIO L (UNII: L8 3710 8 USY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:4240 6 -0 53-0 4

1 in 1 BOX

0 4/0 1/20 19

1

4.3 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 4/0 1/20 19

Labeler -

Fresh, Inc. (021403729)

Revised: 4/2019

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