SHIMMERY SUN- octinoxate titanium dioxide lotion

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

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Active ingredient:
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
Available from:
CA-BOTANA INTERNATIONAL
INN (International Name):
OCTINOXATE
Composition:
OCTINOXATE 4.536 g in 113.4 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen
Authorization status:
OTC monograph final
Authorization number:
35192-012-02

SHIMMERY SUN- octinoxate titanium dioxide lotion

CA-BOTANA INTERNATIONAL

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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Sunscreen Shimmery Sun

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.

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin

cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a

water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months:

Ask a doctor. Sun protection measurements. 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 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-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and

direct sun

ALANINE, ALOE VERA LEAF, ARGININE, ASCORBIC ACID, ASCORBYL PALMITATE,

.ALPHA.-BISABOLOL, (+/-)-,CAPRYLIC/CAPRIC MONO/DIGLYCERIDES, CETEARYL

ISONONANOATE, CETYL ALCOHOL, CITRIC ACID MONOHYDRATE, COCONUT,

ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL MONOSTEARATE, GLYCINE,

SUNFLOWER OIL, MICA, NIACIN, OLEA EUROPAEA LEAF, PANTHENOL,

PHENOXYETHANOL, LECITHIN, SOYBEAN, POTASSIUM SORBATE, SODIUM

PYROPHOSPHATE, PENTYLENE GLYCOL, PROPANEDIOL, ALMOND OIL, ROSA

MOSCHATA OIL, ROSEMARY, HYALURONATE SODIUM, SODIUM CITRATE, SORBITAN,

TOCOPHEROL, UREA, GRAPE SEED OIL, XANTHAN GUM, WATER

Sunscreen

For external use only.

Avoid contact with eyes.

Keep out of reach of children.

Do not apply to open wounds.

STOP USE AND ask a doctor if condition worsens or

symptoms persist for more than seven days, discontinue

use of the product.

Titanium Dioxide, Octinoxate

Package label principal display panel

SHIMMERY SUN

octinoxate titanium dioxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:3519 2-0 12

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

4.536 g in 113.4 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

5.6 7 g in 113.4 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALANINE (UNII: OF5P57N2ZX)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

ARGININE (UNII: 9 4ZLA3W45F)

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)

ASCO RBYL PALMITATE (UNII: QN8 3US2B0 N)

.ALPHA.-BISABO LO L, ( +/-) - (UNII: 36 HQN158 VC)

CAPRYLIC/CAPRIC MO NO /DIGLYCERIDES (UNII: U72Q2I8 C8 5)

CETEARYL ISO NO NANO ATE (UNII: P5O0 1U9 9 NI)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

CO CO NUT (UNII: 3RT3536 DHY)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

GLYCERIN (UNII: PDC6 A3C0 OX)

CA-BOTANA INTERNATIONAL

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

GLYCINE (UNII: TE76 6 0 XO1C)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

MICA (UNII: V8 A1AW0 8 8 0 )

NIACIN (UNII: 26 79 MF6 8 7A)

O LEA EURO PAEA LEAF (UNII: MJ9 5C3OH47)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

SO DIUM PYRO PHO SPHATE (UNII: O3528 6 4B8 Z)

PENTYLENE GLYCO L (UNII: 50 C130 7PZG)

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

ALMO ND O IL (UNII: 6 6 YXD4DKO9 )

RO SA MO SCHATA O IL (UNII: J9 9 W255AWF)

RO SEMARY (UNII: IJ6 7X351P9 )

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

UREA (UNII: 8 W8 T178 47W)

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

XANTHAN GUM (UNII: TTV12P4NEE)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:3519 2-0 12-0 2

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

11/0 7/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 6 /0 1/20 12

Labeler -

CA-BOT ANA INT ERNAT IONAL (106276728)

Registrant -

RODOLFO UGELST AD (106276728)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

CA-BOTANA INTERNATIONAL

10 6 276 728

ma nufa c ture (3519 2-0 12)

Revised: 12/2019

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