MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide stick

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

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
RECOVERY CARE PRODUCTS, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
SUNSCREEN HELPS PREVENT SUNBURN
Authorization status:
OTC monograph final
Authorization number:
72525-003-01

MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide stick

RECOVERY CARE PRODUCTS, 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.

----------

RECOVERY CARE PRODUCTS - MINERAL SUNSCREEN SPF 30

ACTIVE INGREDIENT:

ZINC OXIDE 20%

PURPOSE:

SUNSCREEN

USES:

HELPS PREVENT SUNBURN

WARNINGS:

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 SWALLOWED, GET MEDICAL HELP OR

CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS:

PLEASE ADHERE TO YOUR PHYSICIAN'S PROTOCOL FOR THIS PRODUCT*

WOULD MUST BE FULLY CLOSED AND NO LONGER SCABBED

GENTLY GLIDE OVER SCAR 15 MINUTES PRIOR TO SUN EXPOSURE

REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING, IMMEDIATELY AFTER

TOWEL DRYING, EVERY TWO HOURS

CHILDREN UNDER 6 MONTHS: CONSULT YOUR PHYSICIAN

FOR OPTIMAL RESULTS, USE IN CONJUNCTION WITH RCP SCAR MANAGEMENT*

*FOR MORE INFORMATION ON PROTOCOLS VISIT

WWW.RCPCARE.COM/RECOVERYRESOURCES

OTHER INFORMATION:

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS:

ALOE BARBADENSIS LEAF JUICE (ALOE VERA)*, BUTYROSPERMUM PARKII (SHEA)

BUTTER*, CERA ALBA (BEESWAX)*, COCOS NUCIFERA (COCONUT) OIL*, COPERNICIA

CERIFERA (CARNAUBA) WAX*, EUPHORBIA CERIFERA CERA (CANDELILLA) WAX,

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, RICINUS COMMUNIS (CASTOR) SEED

OIL*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL

*CERTIFIED ORGANIC INGREDIENTS

MINERAL SUNSCREEN BROAD SPECTRUM SPF 30

zinc oxide stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:72525-0 0 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

20 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

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

SHEA BUTTER (UNII: K49 155WL9 Y)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

CANDELILLA WAX (UNII: WL0 328 HX19 )

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

CASTO R O IL (UNII: D5340 Y2I9 G)

RECOVERY CARE PRODUCTS, LLC

CASTO R O IL (UNII: D5340 Y2I9 G)

CO CO A BUTTER (UNII: 512OYT1CRR)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:72525-0 0 3-0 1

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

11/20 /20 18

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

11/20 /20 18

Labeler -

RECOVERY CARE PRODUCT S, LLC (081338122)

Revised: 4/2019

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